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Regulations.gov documents

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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2020-V-1634-0001.

  1. FDA-2010-P-0216-0011Appendix A - "Pre-NDA between FDA and GlaxoSmithKline, Minutes of a Meeting, July 21…
  2. FDA-2017-R-1196-0001NTSO Complaint Issued to Quick N Easy Market, LLC d/b/a Carolina A Market
  3. FDA-2012-P-0555-0005FDA/CDER to Teva Pharmaceutical Industries Ltd - Petition Denial
  4. FDA-2018-H-1769-0001Complaint
  5. FDA-2025-H-2174-0001Complaint
  6. FDA-2015-H-3501-0001CTP CMP Case re Precise Investing, LLC d/b/a Quick Mart / ZX
  7. FDA-1985-V-0011-0001Approval for Variance from FDA to Peachtree Laser Inc.
  8. FDA-2007-E-0105-0022USPTO to FDA/CDER - Notice of Final Determination - Letter
  9. FDA-2015-S-0024-0124NBTY Inc - Mega Vita Min supplements - Premium performance formula
  10. FDA-2024-H-0493-0001Complaint
  11. FDA-2024-H-3560-0001Complaint
  12. FDA-2020-D-2024-0004Request for Extension from Pharmaceutical Distribution Security Alliance (PDSA)
  13. FDA-1997-S-0006-1175Gilad & Gilad, LLC to FDA Center for Food Safety and Applied Nutrition Division of Dietary…
  14. FDA-2002-D-0093-0002Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and…
  15. FDA-2016-S-0024-16932Perrigo Co - Target up & up® - cranberry - helps support urinary tract health
  16. FDA-2024-H-0450-0001Complaint
  17. FDA-2016-N-0124-0077Reference 33 - Comments from docket FDA-1975-N-0012 re Safety and Effectiveness of…
  18. FDA-2015-N-0101-0782Reference 13-21 - Product Labels in OTC Vol. 03 HCATFM Mexsana Medicated Powder…
  19. FDA-2002-N-0265-0019National Electrical Manufacturers Association - Electronic Request for Appearance
  20. FDA-2023-N-3902-0341Comment from Lisa Brikowski
  21. FDA-2014-N-0189-5325Request for Extension from Anonymous
  22. FDA-2014-N-0189-6049Request for Extension from Anonymous
  23. FDA-2017-S-0024-04772017-5884 DH BioScience, LLC - DH Stemogen HA - Supports your immune system, Supports…
  24. FDA-2020-H-0077-0001Complaint
  25. FDA-2015-H-4671-0001CTP CMP Case Re GX Louisiana LLC d/b/a Texaco / Food Mart
  26. FDA-2014-H-1059-0001Complaint
  27. FDA-2023-H-2997-0001Complaint
  28. FDA-2016-P-1180-0041Appendix 10 - Chen HL 2001 -Constipation re APPENDIX TABLE OF CONTENTS re AdvantaFiber…
  29. FDA-2021-S-0024-10542021-001367 - EVOLU RESEARCH - SCURMA FIZZY NEW - SUPPORT ANTIOXIDANT
  30. FDA-2025-H-0740-0001Complaint
  31. FDA-2017-H-1737-0001CMP Complaint Issued to Owl Shop, LLC d/b/a Owl Shop
  32. FDA-2015-V-0396-0002Acknowledgement Letter from FDA DDM to National Aeronautics and Space Administration…
  33. FDA-2013-N-0001-0003Science Board to the Food and Drug Administration Meeting
  34. FDA-2016-Q-1523-0135Sevo acceptance of 90-day extension
  35. FDA-2016-H-1760-0001Complaint
  36. FDA-2022-D-0760-0002Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials Guidance…
  37. FDA-2023-H-2445-0001Complaint
  38. FDA-2015-S-0024-2088NBTY, Inc. - U-Cubes™ - Supports bone health
  39. FDA-2022-V-0264-0001Variance Application from Top Level Productions
  40. FDA-1997-S-0039-2566Perrigo Company of South Carolina - Meijer™ - Glucosamine Chondroitin - Glucosarnine &…
  41. FDA-2016-E-1882-0001Patent Extension Application from Novartis Pharmaceuticals Corp.
  42. FDA-2017-E-5055-0005Determination of Regulatory Review Period for Purposes of Patent Extension; EDWARDS…
  43. FDA-2010-S-0664-2568Schwabe North American, Inc. - Alive - Support Heart Health
  44. FDA-2023-N-3902-1189Comment from Stephanie Dix
  45. FDA-2023-N-3167-0049Pepaxto Final Decision Letter dated 2 23 2024
  46. FDA-2024-E-0475-0007Determination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITY
  47. FDA-2013-N-1524-1919Nomination Letter Ranitidine HCl re: Comment from Fagron
  48. FDA-2022-S-0024-06122022-000636 - Madison One Acme Inc. - Yulam Long Dan Xie Gan Wan Herbal Supplement…
  49. FDA-2016-H-0277-0001CTP CMP re DNNS L.L.C. d/b/a Star Mart
  50. FDA-2016-E-2479-0007Letter from FDA CDER to The Honorable Andrei Iancu
  51. FDA-2024-H-4808-0001Complaint
  52. FDA-2003-N-0048-0003Transcript of the June 24, 2003 ICH Public Meeting
  53. FDA-2007-P-0415-0002HARMD (Helping America Reduce Methadone Deaths) - Citizen Petition
  54. FDA-2010-S-0664-2136Perrigo - TopCare Century Senior - Bone Health
  55. FDA-2015-S-0024-2872NBTY, Inc. - Vitamin C - Vitamin C helps the body's cells fight potential oxidative damage…
  56. FDA-2016-S-0024-1577Perrigo Company of South Carolina - Careone® - Eye Health - Eye Health
  57. FDA-2010-S-0665-0180NDI 662, Herbal Dietary Supplement Tonic from Abba Herbal Preparations.
  58. FDA-2024-N-5381-0003Reference 16 Thematic Analysis of State Medicaid Buprenorphine
  59. FDA-1982-N-0005-0101Correction from Aspirin Foundation of America, Inc.
  60. FDA-2018-H-1950-0001Complaint
  61. FDA-2025-H-0898-0001Complaint
  62. FDA-1992-V-0040-0006Request for Extension of Compliance Date from Walt Disney Productions Disneyland Resort
  63. FDA-2016-H-0767-0002Complaint
  64. FDA-1981-N-0042-0001Interim Response Letter from FDA CDER to Olsson, Frank & Weeda, PC
  65. FDA-2016-S-0024-1562Perrigo Company of South Carolina - Rugby®- 4X Probiotic - Probiotics contribute to a…
  66. FDA-2019-V-5158-0002Acknowledgment Letter from DMS to Royal Event LLC
  67. FDA-1995-P-0016-0175Background Material in 94P-0390
  68. FDA-2013-H-1201-0001Complaint
  69. FDA-2024-H-5778-0001Complaint
  70. FDA-1975-N-0012-0725Request for Extension from American Cleaning Institute
  71. FDA-2018-S-0024-03082018-2206 NOW - MULTIPLE CLAIMS (7)
  72. FDA-2012-V-0095-0002Acknowledgement Letter to Septagon Cages
  73. FDA-2020-R-2012-0001Complaint
  74. FDA-2023-P-5368-0006Completeness Assessment Correspondence
  75. FDA-1980-P-0013-0001memorandum
  76. FDA-2010-P-0275-0003Determinations that Product Withdrawal From Sale Was Not for Reasons of Safety or…
  77. FDA-2024-S-0024-07382024-001575 - DOVITA NUTRITION HEALTH LLC - Supports Healthy Seasonal Immune Function…
  78. FDA-1998-P-0074-0029Kraft Foods, Inc. - Request for Extension of Temporary Marketing Permit
  79. FDA-2023-H-3015-0001Complaint
  80. FDA-2021-P-1141-0001Citizen Petition from Harry Duty
  81. FDA-2018-N-3091-0002Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
  82. FDA-2000-N-0042-0003Building Effective Partnerships Duke University Medical Center (4/12/2000) [page 1 thru…
  83. FDA-2016-V-3673-0005Attachment 3 LPR-1 Typical Show Setup .... Page 32 re Variance Application from Nathan…
  84. FDA-2017-H-3313-0001CMP Complaint Issued to Beck Oil Company of Illinois d/b/a Beck’s / Phillips 66
  85. FDA-2011-N-0918-0003NIH National Institute of Child Health and Human Development (A0007 part 3 of 5)…
  86. FDA-2022-E-2101-0006Letter from U.S. Patent and Trademark Office to FDA CDER
  87. FDA-2020-D-1350-0001Guidance for Industry; Providing Regulatory Submissions in Electronic or Paper Format to…
  88. FDA-1997-S-0006-0945HFS-810 to Physicians Laboratories - Letter - Let 616
  89. FDA-2019-P-3877-0003Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850…
  90. FDA-1997-S-0039-2434Perrigo - equaline - One Daily Women's - Provides Nutritional Support during PMS and…
  91. FDA-2011-S-0932-1053NBTY, Inc. (Giant Eagle Odorless Omega-3 Fish Oil Supplements)
  92. FDA-2013-P-1079-0003Interim Response from FDA CDER to Ropes Gray LLP Sidley Austin LLP
  93. FDA-2011-N-0504-0192Withdrawal from Neuro Fitness, LLC
  94. FDA-2018-H-2349-0001Complaint
  95. FDA-2019-P-2945-0015Attachment M FDA Laboratory Reports on Cannabis Products (2015 and 2016) pages Ml to M7 re…
  96. FDA-1997-S-0006-0978HFS-810 to Soft Gel Technologies, Inc. - Letter - Let 649
  97. FDA-2020-P-1478-0048Interim Response Letter from FDA CFSAN to The Sugar Association
  98. FDA-2022-H-2750-0001Complaint
  99. FDA-1982-N-0005-0115List of References 1-11
  100. FDA-2014-V-0606-0002Variance Application from Laser Safety Services (ER Productions)
  101. FDA-2016-S-0024-0888Natrol - Biotin Plus - 5000 mcg of Biotin supports the growth of healthy hair and strong…
  102. FDA-2015-S-0024-2870NBTY, Inc. - Men's Multivitamin Gummies - General Health
  103. FDA-2023-H-2745-0001Complaint
  104. FDA-2003-N-0427-0029Background Material
  105. FDA-2016-N-3120-05070000_M3_Des and Comp of Drug Product
  106. FDA-1990-G-0398-0018A5 Physicochemical, Microstructural and Microbiological Characterization of a Beta 1L, pH…
  107. FDA-2023-N-2177-7020Reference 170 - Comment to the Docket from Association of Pathology Chairs Re: Docket No…
  108. FDA-2010-N-0598-0010Agency Information Collection Activities; Proposed Collection; Comment Request; Current…
  109. FDA-2022-P-0237-0001Citizens Petition from Timothy R. Cote
  110. FDA-2008-E-0194-0001Pfizer Inc. - Patent Term Extension Application
  111. FDA-2016-N-4620-0003Agency Information Collection Activities; Announcement of Office of Management and Budget…
  112. FDA-2019-E-3052-0001USPTO Letters of March 13, 2019 Concerning Patent Term Extension Applications Based on the…
  113. FDA-2009-S-0607-1672Lang Naturals, Inc. - Walgreen's Finest Natural brand Women's 50+ Advanced dietary…
  114. FDA-2017-H-2404-0001CMP Complaint Issued to 2701 Canal Street, LLC d/b/a Exxon
  115. FDA-1993-G-0218-0347Reference 475/Tab 11 - Researchers Seek Best Way to Assess Fiber In Dog Food re Canadian…
  116. FDA-2013-H-1486-0001Complaint
  117. FDA-2016-N-3120-0367Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)
  118. FDA-2015-H-4096-0002Complaint
  119. FDA-1997-S-0039-2551Perrigo Company of South Carolina - GoodSense® - C - Vitamin C is an antioxidant that…
  120. FDA-1984-N-0259-0339Certificate of Service re: Reply to Motion from Mead Johnson and Company
  121. FDA-2003-S-0732-0028NDI 128 - Iron Aid - SUPPORTING & RELATED MATERIALS
  122. FDA-2022-S-0024-07152022-000754 - Swanson Health Products 11658148874- Swanson Heath Products, MENTAL balance…
  123. FDA-2015-S-0024-0857Renew Life Formulas, Inc. - Ultimate Flora Probiotic Fizzy Drink Mix 10 Billion , Renew…
  124. FDA-2012-N-1021-0072Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal…
  125. FDA-2020-D-1138-0159Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During…
  126. FDA-1997-S-0006-1456Courtesy letter from CFSAN to Phytomatrix Natural Technologies
  127. FDA-2014-N-1021-0004Reference 2. Garber - Standards Used to Detect and Quantify Fermented and Hydrolyzed…
  128. FDA-2016-S-0024-1183Perrigo Company of South Carolina - Smart sense® - hair, skin & nails - Antioxidants help…
  129. FDA-2023-N-4066-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
  130. FDA-2025-H-5851-0001Complaint
  131. FDA-1995-N-0200-0003Tab 4 - University of Pittsburgh - Appearance Request
  132. FDA-2015-P-0095-0002Attachment 6 Citizen Petition From DuVal and Associates (Leonhard Lang, GmbH)
  133. FDA-2019-H-4847-0001Complaint
  134. FDA-2017-H-4555-0001CMP Complaint Issued to 6th Street Pub, Inc. d/b/a Chucks Bar
  135. FDA-2023-V-3546-0003Variance Approval Letter from FDA CDRH to Myles Frohling
  136. FDA-2010-S-0664-1236North American Pharmacal, Inc. - D'Adamo Personalized Nutrition®, Ocubright - Advanced…
  137. FDA-2023-H-5414-0001Complaint
  138. FDA-2011-N-0320-0002Reference 1 - U.S Food and Drug Administration Claims That Can Be Made for Conventional…
  139. FDA-2024-H-4356-0001Complaint
  140. FDA-2025-V-2984-0003Variance Approval Letter from Christopher Marone
  141. FDA-2017-H-1580-0001CMP Complaint Issued to Bob Brandi Stations, Inc. d/b/a Pitt Stop 43
  142. FDA-2016-V-1217-0003Variance Approval from FDA CDRH to DJ MARK RAMBO
  143. FDA-2018-H-3441-0001Complaint
  144. FDA-2010-D-0451-0002Guidance for Industry; Suicidality: Prospective Assessment of Occurrence in Clinical…
  145. FDA-2022-E-0660-0004Determination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45
  146. FDA-2015-H-4578-0001CTP CMP Case re Space Coast Petro Distributor, Inc. d/b/a Shell / Sunshine Food Mart 24
  147. FDA-1978-N-0018-0324FDA
  148. FDA-2015-Q-2352-0013Attachment 31 Open Access Manuscript from NIH re Health Claim Petition from EAS Consulting…
  149. FDA-2021-S-0024-03132021-000513 Jarrow Formulas Inc- Jarrow Formulas Co-Q10- supporting mitochondrial health…
  150. FDA-2015-H-1468-0001Complaint
  151. FDA-2013-H-0097-0001Complaint
  152. FDA-2025-S-0024-15642025-001687 - Vimergy LLC - Vimergy, Ashwagandha Brain Body Relax* - Brain Body Relax
  153. FDA-2008-N-0039-0015Intramammary Dosage Forms; Cephapirin Benzathine
  154. FDA-2009-S-0608-0056NDI 576 - PEP2COMFORT - Original NDI Notification
  155. FDA-2017-H-6860-0001Complaint
  156. FDA-2023-V-3660-0003Variance Approval Letter from FDA CDRH to Robert Rigdon
  157. FDA-2025-H-5265-0001Complaint
  158. FDA-2016-D-2335-1707Tab B - Healthy RIA - comparison OMB original (6-10-24) to OMB final version (11-14-24)
  159. FDA-2018-N-4626-0726Nomination from Wedgewood Pharmacy
  160. FDA-2017-H-5298-0001Complaint
  161. FDA-2007-D-0369-1550PSG_022021 - Draft Guidance on Ramipril
  162. FDA-2020-V-2082-0002Acknowledgement Letter from FDA DMS to Visual Boss
  163. FDA-2003-D-0198-0002Guidance
  164. FDA-2017-D-0085-0023Reference-23-About-FEMA-GRAS-Program re Best Practices for Convening a GRAS Panel…
  165. FDA-2012-N-0438-0003Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food…
  166. FDA-2003-P-0229-0001Acknowledgment Letter from FDA DMB to Karen A. Sisson
  167. FDA-2004-P-0215-0037Hill Dermaceuticals, Inc. - Supplement
  168. FDA-2012-N-0001-0065Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections…
  169. FDA-2012-N-0001-0159Fecal Microbiota for Transplantation Public Workshop
  170. FDA-2015-N-5017-0060Reference 59 - CDC, Preventing Allergic Reactions to Natural Rubber Latex in the…
  171. FDA-1978-N-0018-0145Letter from FDA CDER to H. Gordon Ainsleigh, D. C.
  172. FDA-2012-D-1003-0002Small Entity Compliance Guide What You Need to Know About Registration of Food Facilities
  173. FDA-2025-P-6225-00086115-James M.Love( TITUS HILLIS REYNOLDS LOVE )-11-17-2025-Citizen prtition-Appendix V
  174. FDA-2024-N-5471-0122Reference 120 - Odani Prevalence and Disparities in Tobacco 2017
  175. FDA-2017-H-2701-0001CMP Complaint Issued to Golden Days, LLC d/b/a One Stop Smoke Shop / Stars Smoke Shop 170
  176. FDA-2025-S-0024-14732025-001593 - Made by Brave Inc - Ancient and Brave True Creatine 180g - An expertly…
  177. FDA-2023-E-2610-0006Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C
  178. FDA-2008-S-0664-0155NDI 477 - Bacillus subtilis PB6 - Original NDI Notification
  179. FDA-2023-N-1506-0001Methodological Challenges Related to Patient Experience Data; Request for Information and…
  180. FDA-2013-D-0350-0037Use of International Standard ISO 10993-1, `Biological evaluation of medical devices--Part…
  181. FDA-1993-G-0221-0016Appendx F Digestibility Study re: Tara Gum GRAS Affirmation Petition
  182. FDA-2010-N-0259-0001Meetings: Array-Based Cytogenetic Tests; Questions on Performance Evaluation, Result…
  183. FDA-1976-N-0515-0003Notice of Final Rule 21 CFR Parts 74 and 81 FD&C Blue No. 1
  184. FDA-2015-H-1341-0001Complaint
  185. FDA-2010-S-0664-0817North American Pharmacal, Inc. - D'Adamo Personalized Nutrition, Scienca - Supports…
  186. FDA-2015-H-4928-0001CTP CMP Case re La Bodega Restaurant, Corp. d/b/a La Bodega Peruvian Restaurant
  187. FDA-2013-E-0399-0001sanofi-aventis U.S. LLC (Fitzpatrick, Cella, Harper & Scinto) - Patent Extension…
  188. FDA-2019-V-5189-0001Variance Application from Halo Productions
  189. FDA-1988-P-0013-0002FDA
  190. FDA-2023-S-0024-05362023-001093 - Blugenics Innovation Inc - GREENFILLED ENERGY - Helps with energy, vitality…
  191. FDA-2004-D-0367-0004FDA
  192. FDA-2024-N-5471-0188Reference 186 - Mills Sociodemographic Disparities in Tobacco 2022
  193. FDA-2023-H-3835-0001Complaint
  194. FDA-1999-V-0082-0002FDA/CDRH Response to Universal Studios Florida - Approval for Variance
  195. FDA-2020-S-0024-03012020-000399 Western Botanical Medicine- AIRWAYS SUPPORT- support immune and lung health
  196. FDA-2012-P-1107-0025Letter from FDA CDER to Hogan Lovells US LLP and FDA CDRH
  197. FDA-2018-H-0602-0001Complaint
  198. FDA-2023-N-5281-0002Evan Asher Field: Final Debarment Order
  199. FDA-2009-E-0202-0004FDA/CDER to the U.S. Patent and Trademark Office - Letter
  200. FDA-1976-C-0129-0001Ethicon Incorporated Notice of Filing of Petition for Color Additive
  201. FDA-2007-E-0335-0016U.S. Patent and Trademark Office to JONES DAY - Notice of Final Determination and…
  202. FDA-2015-P-2854-0003Attachment 1: Andrew Lewis Affidavit Redacted 
re Citizen Petition from Olsson Frank Weeda…
  203. FDA-2023-N-2177-0089Reference 46 - Letter from Leslie Kux Assistant Commissioner for Policy FDA to Alan Mertz…
  204. FDA-2017-H-1675-0001CMP Complaint Issued to JR Service Station Inc. d/b/a Total / JR Service Station
  205. FDA-2002-N-0265-0059American Medical Systems - Electronic Request for Appearance
  206. FDA-2013-H-1664-0001Complaint
  207. FDA-2012-N-1210-1244Reference 137-28 Role of water-soluble dietary fiber in the management of elevated plasma…
  208. FDA-2013-E-1657-0006Determination of Regulatory Review Period for Purposes of Patent Extension; JUXTAPID
  209. FDA-1996-N-0028-0036FDA/CFSAN Note to File (re Meeting of July 28 ,2003 between the Food and Drug…
  210. FDA-2019-N-3065-0760Reference 165 - Stroke - Symptoms and Causes, 2020
  211. FDA-2023-P-4975-0007Completeness Assessment Correspondence
  212. FDA-2020-N-2029-0290Reference 6 - Carter Practical considerations with 17-Hydroxyprogesterone caproate for…
  213. FDA-2009-S-0608-0155NDI 614 - CaPterin - Original NDI Notification
  214. FDA-2012-N-0115-0006Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
  215. FDA-1978-N-1164-0003Accession No. 88-86-09, Box 4 - Retired
  216. FDA-2015-S-0024-1895NBTY - Immune Support Gummies - Supports immune system health
  217. FDA-2004-P-0009-0005Memorandum between Nancy Boocker and Jennie Butler
  218. FDA-2005-P-0069-0003Petition Approval from FDA CDER to Lachman Consultant Services, Inc
  219. FDA-2014-N-0345-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Data To…
  220. FDA-1997-S-0039-1926Kura Natural, Inc. - Aralium - Extract of Fatsia Japonica - Supports Joint Health and…
  221. FDA-2005-N-0162-0014Thomas, Al
  222. FDA-2019-H-2104-0001Complaint
  223. FDA-2024-S-0024-04062024-001224 - Blueroot Health - Fairhaven Health, Prenatal Multivitamin Essentials with…
  224. FDA-2021-S-0024-13752021-1392 Natural Factors - MULTIPLE CLAIMS (2)
  225. FDA-2011-S-0932-1440Vitacost.com - Vitacost® Natural Silica with Boflavonoids - Adequate silicon intake has…
  226. FDA-2018-N-4626-0182Nomination from Wedgewood Pharmacy
  227. FDA-2007-D-0369-1564PSG_022307 - Draft Guidance on Prasugrel Hydrochloride
  228. FDA-2013-P-1373-0002Acknowledgement Letter to Terry L. Tennant
  229. FDA-2018-V-3783-0004Letter from FDA CDRH to ARIZONA SCIENCE CENTER
  230. FDA-2012-S-1144-1455Now Foods - Protocol for Life Balance Omega 3 Softgels - Supports Cardiovascular Health
  231. FDA-2002-N-0265-0063Alpine Group - Electronic Request for Appearance
  232. FDA-2015-V-0457-0003Variance Approval from FDA CDRH to SUPREME SOUND ENTERTAINMENT
  233. FDA-2023-H-3678-0001Complaint
  234. FDA-2011-S-0932-0173Letter from NBTY, Inc.
  235. FDA-2015-P-1279-0014Citizen Petition Final Response from FDA CTP to Cigar Rights of America
  236. FDA-2012-S-1144-0233Vitacost.com, Inc. - CSI Alpha Lipoic Acid Facial Complex - Advanced nutritional support…
  237. FDA-2012-E-1247-0002U.S. Patent and Trademark Office - Letter
  238. FDA-2020-S-0024-07122020-000868 NOW Foods - Lucky Vitamin, Mushroom Immune Plus - Support Immune System
  239. FDA-2018-S-0024-09062018001945-NOW Foods- NOW Foods Saw Palmetto Berries- Supports a Healthy Prostate
  240. FDA-2015-H-1925-0001Complaint
  241. FDA-2020-E-2258-0006Letter from FDA CDER to the U.S. Patent and Trademark Office
  242. FDA-2023-P-1388-0017Final Response Letter from FDA CDER to McDermott Will & Emery (on behalf of Vanda…
  243. FDA-2016-N-2836-0008Agency Information Collection Activities; Submission for Office of Management and Budget…
  244. FDA-2024-H-3186-0001Complaint
  245. FDA-2015-H-4960-0001CTP CMP Case re A to Z Discount Auto Parts, Inc. d/b/a Cedar Grove Wine and Liquor
  246. FDA-2019-H-5136-0001Complaint
  247. FDA-2020-H-1063-0001Complaint
  248. FDA-2006-N-0107-0005Duplicate
  249. FDA-2018-N-3773-0001Certain Products Containing Bendamustine
  250. FDA-2017-S-0024-05122017000645 - International Vitamin Corporation - MULTIPLE CLAIMS (4)
  251. FDA-2023-N-0002-0020New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New…
  252. FDA-2024-N-5933-0114Vanda Response Submission Cover Letter
  253. FDA-2020-E-2041-0009Requirement for Information
  254. FDA-2022-D-0277-0002Risk Management Plans to Mitigate the Potential for Drug Shortages Guidance for Industry…
  255. FDA-2015-S-0024-0163NBTY Inc - Calcium with Vitamin D3 supplements - Supports bone and teeth health
  256. FDA-2017-P-5477-0005Tab 3 - Andrew M_ Wilson et al_, Importance of drug-device interaction in determining…
  257. FDA-2005-N-0514-0004Supporting Statement
  258. FDA-2019-S-0024-08152019002589- Phytomatrix Natural Technologies Inc.- Sleep Aid- claims to help relieve…
  259. FDA-2016-N-3118-0347220_FDA Study Data
  260. FDA-2014-N-1206-0001Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola…
  261. FDA-2021-S-0024-04212021-000635 Jinke Group USA Inc - TheraPrimE Tocotrienols - Promotes cellular health and…
  262. FDA-2022-S-0024-05812022-000607 - Amazon.com Services, LLC - Multiple Claims (5)
  263. FDA-2014-N-0189-83021Reference 113 Intentions to Smoke Cigarettes Among re Deeming Tobacco Products To Be…
  264. FDA-2009-D-0268-0015Agency Information Collection Activities; Announcement of Office of Management and Budget…
  265. FDA-2018-E-2596-0003Letter to U.S. Patent and Trademark Office from FDA CDER
  266. FDA-1997-S-0039-2828DreamQuest Nutraceuticals - Dreaminol- nutritional support for healthy sleep function
  267. FDA-2018-V-3736-0004Variance Application Renewal from Canal Sound and Light
  268. FDA-2010-N-0107-0018Patricia Lupole - Testimony [4/30/2010 Public Hearing]
  269. FDA-2024-H-0985-0001Complaint
  270. FDA-2023-N-2030-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  271. FDA-2020-S-0024-03822020-000494 SnL Health Group - SnL Health, Super MSM - Supports immune system and joint…
  272. FDA-2020-H-0811-0001Complaint
  273. FDA-2016-V-1208-0002Acknowledgement Letter from FDA DDM to 5 Diamond Productions
  274. FDA-2015-S-0024-2340NBTY, Inc. - Complete Multi-Vitamin Gummies - These gummies contain over 10 Vitamins and…
  275. FDA-2015-S-0024-3499Perrigo - H-E-B®- Glucosamine Chondroitin Complex, Safeway® - Glucosamine Chondroitin…
  276. FDA-2012-S-1144-0935NOW Foods - Pyruvate - Cellular Fuel
  277. FDA-2020-S-0024-1090SFC2020-001286 LifeVantage - LifeVantage AXIO Non Caffeinated - Improves Positive Mood
  278. FDA-2014-N-2244-0196Reference 188 Komancheck_2013_Celebrating 25 years and 100000 acres of preserved farmland…
  279. FDA-2011-M-0848-0001Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  280. FDA-2003-N-0103-0067Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of…
  281. FDA-2008-P-0319-0028FDA to Lauranell H. Burch - Petition Denial
  282. FDA-2023-H-3085-0001Complaint
  283. FDA-2024-E-0162-0006Letter from DLA Piper LLP to FDA CDER
  284. FDA-2024-N-2602-0005Afternoon Transcript for the 2024 Animal Drug User Fee Educational Conference July 17…
  285. FDA-2024-P-0667-0008Reference 3 - Altman D 2002
  286. FDA-2021-S-0024-08872021-001151 - Greeniche Natural Health Inc. - MULTIPLE CLAIMS (2)
  287. FDA-2014-V-0084-0003Variance Approval from FDA CDRH to Ayrton Lasers
  288. FDA-1999-P-0127-0002FDA/CDER to Quinn Consulting Services
  289. FDA-2011-P-0734-0001Richard J. Miller - Citizen Petition
  290. FDA-2023-E-2831-0005Letter from U.S. Patent and Trademark Office to FDA CDER
  291. FDA-1975-N-0248-0118Letter from Honorable Edward Hutchinson to FDA Re: Comment from Menasha Corporation
  292. FDA-2023-S-0023-0050NDI 1292 - Lysoveta-LP19 - Original NDI Notification
  293. FDA-1980-P-0073-0005Acknowledgement Letter from FDA to Coherent Innovations Inc.
  294. FDA-2008-M-0335-0001P070008 - Biotronik, Inc., Stratos LV CRT-P & stratos LV-T CRT-P, corox OTW BP lead &…
  295. FDA-1995-N-0054-13887Background Material for NFR 1
  296. FDA-2013-P-1128-0001Teva Pharmaceutical Industries Ltd - Citizen Petition
  297. FDA-2023-E-3227-0002Patent Extension Application from Kilpatrick Townsend & Stockton LLP (on behalf of uniQure…
  298. FDA-2019-H-4529-0001Complaint
  299. FDA-2018-V-2802-0003Letter from FDA CDRH to PARADISE SOUND AND LIGHT, LLC
  300. FDA-2000-D-0187-0001FDA
  301. FDA-2024-N-5471-0723PRIA Reference 54 Federal Reserve Bank of Philidelphia Inflation Forecasts 2024
  302. FDA-2024-H-4676-0001Complaint
  303. FDA-2018-H-4854-0001Complaint
  304. FDA-2010-S-0664-0868Genexis - High Potency UltraPure Omega-3 Fish Oil - Supports the Functions of the Brain…
  305. FDA-2020-N-2319-0004Request for Extension from Generic Animal Drug Alliance (GADA)
  306. FDA-2024-N-5471-0707PRIA Reference 38 National Center for Health Statistics Survey Description 2020
  307. FDA-2014-N-1051-0907Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by…
  308. FDA-1984-N-0259-0015Exhibit G-3.8 re: Disclosure of Data and Information from Center for Drugs and Biologics…
  309. FDA-2008-P-0584-0002Acknowledgement Letter to Cohen, Tauber, Spievack & Wagner P.C.
  310. FDA-2004-D-0300-0004Guidance for Industry
  311. FDA-1998-D-0035-0013Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3…
  312. FDA-2024-H-2936-0001Complaint
  313. FDA-2006-V-0353-0005FDA/CDRH to Club Rabie, Inc. - Letter
  314. FDA-2004-P-0215-0005FDA/CDER to Hill Dermaceuticals, Inc. - Letter
  315. FDA-2016-P-2532-0003Response letter from FDA to David K. Cundiff
  316. FDA-2023-H-4947-0001Complaint
  317. FDA-2010-P-0317-0002Acknowledgement Letter to Teva Pharmaceutical Industries Ltd.
  318. FDA-2023-S-0024-02982023-000384 - Perelel Health - Perelel Health, Sleep Support Powder - Promotes Relaxation…
  319. FDA-2023-V-2105-0002Acknowledgment Letter from FDA DMS to Rochester Museum and Science Center
  320. FDA-2012-S-1144-1747NBTY, Inc. - Disney Calcium Gummies Plus Vitamin D3 - Calcium plays a vital role in…
  321. FDA-2013-S-0024-0580Perrigo Company (Safeway - Glucosamine Chondroitin Complex) - Letter
  322. FDA-2022-V-0167-0001Variance Application from Kevin Lawson
  323. FDA-2006-P-0323-0003HFA-305 to National Coalition for Cancer Survivorship and American Society of Clinical…
  324. FDA-2015-N-0101-0929Reference 39-64 - FDA-1975-N-0012-0238 --- CP14 re Safety and Effectiveness of Health Care…
  325. FDA-2014-N-0189-3522Request for Extension from Anonymous
  326. FDA-1998-N-0068-0008FDA
  327. FDA-2015-S-0024-2141NBTY, Inc. - Choline Bitartrate Inositol - Essential for nervous system health
  328. FDA-2024-N-5933-0108Syed 2020
  329. FDA-2025-V-1222-0001Variance Application from New Sense Productions, Inc.
  330. FDA-2016-N-3118-04240000_m5_01540040_case report forms re: Mallinckrodt Pharmaceuticals; Proposal to Withdraw…
  331. FDA-2019-S-0024-03102019002299 - Harmony Foods - Promotes digestive health, Increases the feeling of fullness
  332. FDA-2020-V-1096-0001Variance Application from Carrollwood Day School
  333. FDA-2014-N-0189-11394Request for Extension from Anonymous
  334. FDA-2015-E-3855-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  335. FDA-1977-N-0018-0034Letter from FDA/CDER to Miles Laboratories, Inc.
  336. FDA-2024-E-5015-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  337. FDA-2002-D-0091-0001FDA
  338. FDA-1980-N-0038-0353Motion from Ciba-Geigy Corporation (Wald, Harkrader & Ross)
  339. FDA-2016-H-3371-0001Complaint
  340. FDA-2014-N-0189-5457Request for Extension from Vince Tannahill
  341. FDA-2024-V-1530-0003Variance Approval Letter from FDA CDRH to Tim Szeszulski
  342. FDA-2011-N-0197-0017Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption
  343. FDA-2021-V-1137-0002Acknowledgment Letter from FDA DMS to James Dickey
  344. FDA-2019-P-1236-0005Risk-Based Licensing of Biosimilars re Memorandum of Meeting - Listening Meeting with Dr…
  345. FDA-2007-D-0369-1863PSG_020592 - Draft Guidance on Olanzapine
  346. FDA-2007-D-0369-1995PSG_209899 - Draft Guidance on Ozanimod Hydrochloride
  347. FDA-2012-V-0230-0001Castle High School - Application for Variance
  348. FDA-2004-P-0494-0005Citizen Petition from Watson Pharma, Inc.
  349. FDA-1992-N-0006-0012Supplement Letter from Zuckerman, Spaeder, Goldstein, Taylor & Kolker Attorneys at Law on…
  350. FDA-1987-N-0010-0289Background Material
  351. FDA-2019-H-1634-0001Complaint
  352. FDA-1993-N-0057-0021FDA
  353. FDA-2020-D-1136-0056Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions…
  354. FDA-2023-N-3902-1295Comment from Anonymous
  355. FDA-2015-N-0101-0553Reference 11-323 - FDA-1975-N-0012-0283 --- C78 Sections_1_Thru_8) re Safety and…
  356. FDA-2015-S-0024-2614NBTY - Optimal Vision supplements under the CVS label - Supports eye health and healthy…
  357. FDA-2016-N-1111-1652Attachment 7. Patient behavior tracking charts_Part 4 of 4 re Comment from Judge Rotenberg…
  358. FDA-2024-H-4961-0001Complaint
  359. FDA-2004-G-0002-0003Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in…
  360. FDA-2018-N-4626-0154Nomination from Wedgewood Pharmacy
  361. FDA-2017-H-1807-0001CMP Complaint Issued to Friendly Group LLC d/b/a Marion Food Mart
  362. FDA-2009-E-0238-0004FDA\CDER to United States Patent and Trademark Office - Letter
  363. FDA-1977-N-0217-0018Memorandum of Telephone Conversation between FDA, Rice Millers' Association and American…
  364. FDA-2018-H-0186-0001Complaint
  365. FDA-1975-N-0012-0058Letter from FDA to Amway Corporation
  366. FDA-2008-N-0416-0011Ian Illuminato, Friends of the Earth - Testimony
  367. FDA-2002-P-0247-0016See FDA-2002-P-0247-0006
  368. FDA-2023-S-0024-04802022-000307 - MindBodyGreen LLC- MindBodyGreen LLC- supports your body's daily…
  369. FDA-2014-N-1051-0317316 7694105 Lab Subject R3009
  370. FDA-2024-H-0998-0001Complaint
  371. FDA-2016-V-3143-0001Variance Application from Legacy Entertainment
  372. FDA-2016-H-0745-0001CTP CMP Case re Perkins Store LLC d/b/a Perkins Store
  373. FDA-2019-H-2456-0001Complaint
  374. FDA-1998-N-0068-0001FDA
  375. FDA-1998-D-0025-0027Model Application to Manufacture Fludeoxyglucose F-18 Injection for Marketing, September…
  376. FDA-1997-S-0006-0594[LET997] CFSAN/ONLDS Response to Market America, Inc. - Courtesy Letter
  377. FDA-2018-H-0499-0001Complaint
  378. FDA-2025-H-2576-0001Complaint
  379. FDA-2016-C-2570-0006Reference 5 - Memorandum from JPark to MHarry_ 02022017__Redacted
  380. FDA-2009-S-0607-1066Perrigo - Equaline -D - Supports Bone Health and Immune System Function
  381. FDA-2016-N-3118-0107129_FDA Study Subject_Redacted
  382. FDA-2009-N-0025-0015Agency Information Collection Activities; Proposed Collection; Comment Request; Animal…
  383. FDA-2023-N-3902-0132Reference 104 - The role of positive programming in behavioral treatment re Banned…
  384. FDA-2011-S-0932-1467Ardyss International Inc - Pure Noni - Increases energy level
  385. FDA-2006-P-0326-0005Public Citizen - Supplement
  386. FDA-2017-H-6488-0001Complaint
  387. FDA-2025-V-0226-0003Variance Approval Letter from FDA CDRH to Allen Harsted
  388. FDA-2021-S-0024-13442021-001681 - BODYBIO - Calcium Magnesium Butyrate
  389. FDA-2021-P-0124-0005Attachment 3 re Suitability Petition from Hyman, Phelps & McNamara P.C.
  390. FDA-2013-H-1129-0001Complaint
  391. FDA-2013-S-0024-0656Perrigo - Multiple Claims - 10
  392. FDA-2021-N-1349-0379PRIA Reference 70 FDA Memo Internal Analyses Using Data from the 2019 National Survey on…
  393. FDA-2020-H-0316-0001Complaint
  394. FDA-2022-N-2390-0416Exhibit 95 - Herxheimer (2003)
  395. FDA-1982-G-0253-0044Letter from Devro, Inc. to FDA CFSAN
  396. FDA-1992-G-0226-0011Attachment 1: List of Applications Provided In the Original Petition re Letter from The…
  397. FDA-2023-H-3292-0001Complaint
  398. FDA-2025-V-0240-0002Variance Acknowledgment Letter from FDA DMB to Starry Nights, LLC
  399. FDA-2021-V-0103-0003Variance Approval from FDA CDRH to Larry Rummel
  400. FDA-2014-P-1802-0002Acknowledgement Letter from FDA DDM to e5 Pharma LLC
  401. FDA-1987-M-0028-0002Arzco Medical Electronics, Inc.; Premarket Approval of the Arzco Transesophageal Cardiac…
  402. FDA-2012-N-0563-0001Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral…
  403. FDA-2024-E-5279-0003Letter to U.S. Patent and Trademark Office
  404. FDA-2022-E-0676-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  405. FDA-2021-V-0056-0002Acknowledgment Letter for Deluxe Audio Video
  406. FDA-1997-S-0006-1567Courtesy letter and related material from CFSAN to Alurx
  407. FDA-2024-E-0198-0006Letter from FDA CDER to U.S. Patent and Trademark Office
  408. FDA-2016-S-0024-0736Perrigo Company - Promotional - SAM-e is a naturally occurring molecule in the body, which…
  409. FDA-2021-D-0399-0005Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell-and-Tissue-Based…
  410. FDA-2024-H-2632-0001Complaint
  411. FDA-2023-H-4403-0001Complaint
  412. FDA-2025-H-6861-0001Complaint
  413. FDA-2007-D-0369-0719PSG_206488 - Draft Guidance on Eteplirsen
  414. FDA-2012-N-0560-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
  415. FDA-2015-H-4517-0001CTP CMP Case re Meyers Fuel Mart Inc. d/b/a Meyer’s Fuel Mart / Exxon
  416. FDA-2014-N-0189-10124Request for Extension from James Costa
  417. FDA-2022-H-2357-0001Complaint
  418. FDA-2002-N-0304-0003Agency Information Collection Activities; Announcement of OMB Approval; Adverse Experience…
  419. FDA-2022-H-1648-0001Complaint
  420. FDA-2023-V-1752-0003Variance Approval from FDA CDRH to Shakes
  421. FDA-2009-E-0056-0003Letter from FDA/CDER to the U.S. Patent and Trademark Office - Letter
  422. FDA-2024-N-0730-0006Revised TMP Application - Alternate Release Agent
  423. FDA-2009-D-0007-0002Animal Models--Essential Elements to Address Efficacy Under the Animal Rule - Draft…
  424. FDA-2023-H-2170-0001Complaint
  425. FDA-2002-N-0265-0007Johnson and Johnson - Electronic Request for Appearance
  426. FDA-2006-P-0278-0001Acknowledgement Letter from FDA DMB to Arnall Golden Gregory LLP
  427. FDA-2025-P-2526-0073Reference 71 - Vienna Convention on the Law of Treaties, 1155 U.N.T.S. 331…
  428. FDA-1984-G-0174-0062Exhibit 3 - M. C. Porter Memorandum, Letter to the Editor of the Journal of Food…
  429. FDA-1993-N-0065-0002Proposal to Establish Procedures for the Safe Processing & Importing of Fish & Fishery…
  430. FDA-2025-V-3787-0001Variance Application from NXFX
  431. FDA-2016-N-3389-0456Attachment "A" Grain Millers Milling Process vs. Patented Hydrogen Peroxide and Similar…
  432. FDA-2011-S-0932-1466Ardyss International Inc - Coral Calicium - To help nourish your body and skeletal systems
  433. FDA-2014-S-0024-1114Natural Factors Nutritional Products Ltd (Vitamin D3 5000 IU) - Letter
  434. FDA-2018-E-4432-0002Patent Extension Application from Yuji Yamazaki (Kyowa Hakko Kirin Co., Ltd)
  435. FDA-2023-N-2177-7085Reference 235 - FDA, “The Special 510(k) Program; Guidance for Industry and Food and Drug…
  436. FDA-2018-H-4758-0001Complaint
  437. FDA-2007-P-0182-0003sanofi aventis - Citizen Petition
  438. FDA-2016-D-2565-0029510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA)…
  439. FDA-2011-P-0166-0003Attachment 2 - "Prescribing Information Ondasetron Effervescent Tablets 8 mg" - [Lachman…
  440. FDA-2021-N-1309-0109Reference 106 Chen Is Exposure to Secondhand Smoke Associated 2013
  441. FDA-2022-V-2770-0001Variance Application from Divyesh Gajjar
  442. FDA-2014-D-0055-0230Reference 07-009 - Gordinho and Fox_Ripening Blue cheese. Salting rate_1981c
  443. FDA-2010-S-0664-1405Bonus Vitae, LLC. - B-Focused Adult Essential - Brain and Mood Support
  444. FDA-1995-V-0159-0004Variance Approval Response Letter from FDA CDRH to MeshTel
  445. FDA-1987-N-0010-0104Background Material
  446. FDA-2023-N-2177-7203Tab A - Final Rule-OMB Original Version
  447. FDA-1979-N-0008-0026Supplement from USV Pharmaceutical Corporation
  448. FDA-2010-S-0664-1081Cytosport, Inc. - Muscle Milk Light - Lean Muscle Supporting
  449. FDA-1984-N-0259-0023G-3.16 is now Exhibit G-3.16 re: Disclosure of Data and Information from Center for Drugs…
  450. FDA-2019-N-5711-0007Ref. 04. Nomination of Robert Califf to Serve as FDA Commissioner 2015 re Importation of…
  451. FDA-2021-V-0207-0002Acknowledgment Letter from FDA DMS to Projector Reviews.com
  452. FDA-2013-N-0723-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of…
  453. FDA-2019-N-3065-0229PRIA Reference 6 - Self-reported exposure to tobacco warning labels among US middle and…
  454. FDA-2014-N-0189-3089Request for Extension from Anonymous
  455. FDA-2007-D-0369-1803PSG_020033 - Draft Guidance on Benazepril Hydrochloride; Hydrochlorothiazide
  456. FDA-1997-S-0039-2980Country Life - Go Less - Supports Healthy Bladder Activity
  457. FDA-1977-N-0014-0826Answer Letter from FDA to Comment from The Honorable James M. Hanley, United States House…
  458. FDA-2022-V-1557-0001Variance Application from The Mockery Brand
  459. FDA-1975-N-0269-0001Vinyl Chloride Polymers in Contact With Food
  460. FDA-2008-P-0519-0001Golden Orchid, Ltd. - Citizen Petition
  461. FDA-2018-S-0024-01372018001300 - Innovix Pharma, Inc - InnovixLabs Purified Omega-7 - help maintain healthy…
  462. FDA-2018-S-0024-05302018001639- Ortho Molecular Products, Inc- MITOCORE PROTEIN BLEND- increase cellular…
  463. FDA-2024-P-3567-0001Suitability Petition from Lachman Consulting Services, Inc.
  464. FDA-2019-D-0661-15417Guidance: Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed…
  465. FDA-2019-H-2647-0001Complaint
  466. FDA-1997-S-0006-1397Courtesy Letter from CFSAN to Lysulin, Inc.
  467. FDA-2014-H-1918-0001Complaint
  468. FDA-2013-N-0375-0001Agency Information Collection Activities; Proposed Collection Comment Request; Agreement…
  469. FDA-2015-S-0024-0479Perrigo - sunmark® - Calcium - For Bone Strength and Flexibility
  470. FDA-2013-H-0149-0001Complaint
  471. FDA-2019-H-2701-0001Complaint
  472. FDA-2015-H-3626-0001CTP CMP Case re Aro Systems, Inc. d/b/a Aro Mart / Phillips 66.
  473. FDA-2016-H-0475-0001CTP CMP Case re The Brown Lantern Ale House, Ltd., d/b/a Brown Lantern Ale House
  474. FDA-2021-P-1115-0014Exhibit L re Citizen Petition from Professional Compounding Centers of America
  475. FDA-2011-S-0932-2038Arbonne International, LLC - Arbonne Essentials Calcium Plus - Reduce the risk of…
  476. FDA-2024-P-4159-0008Completeness Assessment Correspondence
  477. FDA-1997-S-0006-2129Courtesy letter and related material from CFSAN to Steeped Fine Loose Teas & Accessories…
  478. FDA-2012-V-0648-0003FDA/CDRH Response to Dark Horse - Approval for Variance
  479. FDA-2017-H-3696-0001CMP Complaint Issued to Supermesa Fuel and Merc, LLC d/b/a Superpumper 12 / Shell
  480. FDA-2006-P-0338-0119FDA/CFSAN Nutrition Memo Final August 29, 2013 - Memorandum
  481. FDA-2013-P-0148-0002Acknowledgement Letter to Crowell & Moring LLP
  482. FDA-2003-D-0431-0034Attachment C "Gas What" Policy Question on Medical Gases re: Comment from Air Liquide…
  483. FDA-1980-N-0066-0039Answer Letter from FDA OLA to Comment from the Honorable Silvio Conte, United States House…
  484. FDA-2012-V-0415-0006Amendment for Company Name Change Request - Precision Lasers - FW Lasers
  485. FDA-2023-E-3302-0004Letter from U.S. Patent and Trademark Office to CDER
  486. FDA-2021-S-0024-02192021-000253 Atrium-Innovations - Genestra Brands - Helps support cognitive health and…
  487. FDA-2006-P-0025-0007Sanofi-aventis US LLP - Reference 32 - U.S. Patent No. 6,476,068
  488. FDA-2013-V-1699-0001Variance Application from Velocity Audio Visual, Inc.
  489. FDA-2016-S-0024-0435EuroPharma Inc - CuraPro® with DIM - Supports healthy estrogen balance and metabolism
  490. FDA-1993-G-0220-0006Section 2 - Proposed Regulation Under 21 C. F. R. 184.
  491. FDA-2024-E-0218-0005Letter from FDA CDER to U.S. Patent and Trademark Office
  492. FDA-2011-S-0933-0010NDI 676 Creatyl-L-Glutamine from Vital Pharmaceuticals, Inc. Re Background Material…
  493. FDA-2007-A-0279-0003Advisory Opinion Petition from AFrame Digital Inc
  494. FDA-2005-N-0464-0229Compressed Gas Association - Supplement Comment [re FDA-2005-N-0464-0080.1]
  495. FDA-2025-D-0610-0001Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry…
  496. FDA-2015-S-0024-1719America's Finest, Inc. - Beta I, 3 Glucan Dietary Supplement - Helps support and promote a…
  497. FDA-2022-H-2879-0001Complaint
  498. FDA-2003-N-0316-0001FDA
  499. FDA-2014-N-2235-0002Draft Environmental Assessment for Investigational Use of Aedes aegypti OX513A re Draft…
  500. FDA-2025-V-0703-0002Variance Acknowledgment Letter from FDA DMB to Rgray Photography
  501. FDA-2012-S-1144-1764NBTY, Inc. - Joint Soother Glucosamine Chondroitin MSM with Omega 3, 6, 9 - Lubricates…
  502. FDA-2015-V-1244-0002Acknowledgement Letter from FDA DDM to Specialized Sound & Light
  503. FDA-2019-E-3014-0005Determination of Regulatory Review Period for Purposes of Patent Extension; RECELL…
  504. FDA-1987-N-0010-0199Background Material
  505. FDA-2021-S-0024-14322021-001562 - Careof- CAREOF VITAMIN D- SUPPORTS CALCIUM ABSORPTION
  506. FDA-1997-S-0006-0620HFS-456 to Health from the Sun - Letter - Let 309
  507. FDA-2024-V-3006-0002Acknowledgment Letter from FDA DMS to Osuorji LLC
  508. FDA-2015-S-0024-3591AmPurity Nutraceuticals - Whey Strong - Each sport requires a specific set of physical and…
  509. FDA-2011-N-0090-0001Unique Device Identification System
  510. FDA-2023-N-3902-0699Comment from Helen Schietinger
  511. FDA-2025-S-0024-16022025-001725 - Swanson Health Products - Swanson Health Products, Thyme Leaf - Traditional…
  512. FDA-2006-D-0464-0011FDA/OC
  513. FDA-2018-S-0024-03352018-2596 Nutrition Express - MULTIPLE CLAIMS (3)
  514. FDA-2019-M-3862-0001Premarket Approval Response from FDA CDRH to CVRx, Inc.
  515. FDA-2010-N-0168-0013Developing Guidance on Naming Labeling, and Packaging Practices to Minimize Medication…
  516. FDA-2025-S-0024-00372025-000081 - Nestle Health Science - Vital Proteins Colostrum Capsules- Supports Gut…
  517. FDA-2018-V-3783-0001Variance Application from Arizona Science Center
  518. FDA-2009-P-0426-0005Medical Technology and Practice Patterns Institute - Supplement
  519. FDA-2020-P-2048-0001Citizen Petition from Fresenius Kabi USA, LLC
  520. FDA-2013-H-1454-0001Complaint
  521. FDA-2018-H-2005-0001Complaint
  522. FDA-2015-S-0024-0722Perrigo Company of South Carolina - Amazon.com - Promotional - Nutrients your child needs…
  523. FDA-2016-H-3993-0001Complaint
  524. FDA-2004-E-0270-0002FDA/CDER to US Patent and Trademark Office - Letter
  525. FDA-2018-N-3207-0001Request for Nominations of Voting Members on a Public Advisory Committee; National…
  526. FDA-2016-N-1024-0001Preparation for International Cooperation on Cosmetics Regulation
  527. FDA-2023-N-3902-0496Comment from Delene St. Clair
  528. FDA-2020-S-0024-03862020-000499 Dreambrands - Mdrive Start - Supports healthy cortisol for stress management…
  529. FDA-2009-P-0150-0003Center for Devices and Radiological Health to Arthur K. Yellin, MS, RPh - Letter
  530. FDA-2002-S-0531-0040NDI 114 - BioDiamed (Mormadica charantia L.) - Original NDI Notification
  531. FDA-2021-S-0024-12252020-4316 Sanmedica International - SeroVital Rapid Dissolve Powder
  532. FDA-2015-N-3392-0001Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal…
  533. FDA-1997-S-0540-0022NDI 15 - Huperzine A, an alkaloid compound extracted from the herb Huperzia Serrata from…
  534. FDA-2016-S-0024-0904Herbal Zap - Herbal Zap Immune Support - Ancient Ayurvedic Herbal Blend for Immune Support
  535. FDA-2013-S-0024-0297NBTY Inc (Hydrolyzed Collagen) - Letter
  536. FDA-2014-V-0286-0002Variance Application from Ray Nieves
  537. FDA-2023-D-0466-0002Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder…
  538. FDA-2007-P-0058-0001Acknowledgement Letter from FDA / DDM to Keller And Heckman LLP
  539. FDA-2021-D-1146-0042Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and…
  540. FDA-2008-N-0153-0001Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
  541. FDA-2007-P-0008-0002See FDA-2007-P-0008-0001
  542. FDA-2023-H-5647-0001Complaint
  543. FDA-1990-N-0025-0001Food Labeling; Declaration of Ingredients, RIN 0905-AD08 - Notice of Proposed Rule (pgs…
  544. FDA-2025-H-0586-0001Complaint
  545. FDA-1997-S-0039-2424Perrigo - equaline - E - Vitamin E is an antioxidant. It works to protect cell membranes…
  546. FDA-2023-H-5724-0001Complaint
  547. FDA-2011-S-0932-0753NBTY, Inc. (American Health et al Calcium with D3 Supplements)
  548. FDA-2013-E-0034-0003FDA/CDER to U.S. Pantent and Trademark Office - Letter
  549. FDA-2011-S-0932-2048Vitacost.com, Inc. d/b/a Nutraceutical Sciences Institute - NSI Bitter Melon Fruit…
  550. FDA-2024-V-0250-0001Variance Application from Joseph Ashton
  551. FDA-2017-H-3863-0001CMP Complaint Issued to NBA Discount Liquors, LL, d/b/a NBA Discount Liquors
  552. FDA-1978-N-0899-0042Withdrawal of Certain Pre-1986 Proposed Rules; Final Action; Withdrawal of Proposed Rules
  553. FDA-2019-H-0955-0001Complaint
  554. FDA-1993-N-0448-0003Laser Products; Proposed Amendment to Performance Standard - Notice of Proposed Rule
  555. FDA-2018-V-4172-0002Acknowledgment Letter from FDA DDM to Walt Disney Parks & Resorts US
  556. FDA-2017-D-0154-0061Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for…
  557. FDA-2019-H-0288-0001Complaint
  558. FDA-2017-H-3024-0001CMP Complaint Issued to Speedway LLC d/b/a Speedway
  559. FDA-2005-N-0345-0001Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as…
  560. FDA-2011-P-0064-0042FDA/CDER to Barbara L. Maw, P.C. - Petition Denial
  561. FDA-2018-V-4177-0002Acknowledgment Letter from FDA DDM to Walt Disney Parks & Resorts US
  562. FDA-2025-S-0024-13332025-001434 - Harmony Foods LLC. - Equate Black Elderberry Gummies 60ct - Helps support…
  563. FDA-2010-S-0664-2330Perrigo - H-E-B Senior Complete - help support heart health
  564. FDA-2004-V-0289-0003HFZ-300 to Linden Laser Systems - Approval for Variance
  565. FDA-2015-E-2576-0006Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE
  566. FDA-2015-S-0024-0472Perrigo - Walgreens - Glucosamine Chondroitin - Chondroitin - is a key ingredient that…
  567. FDA-2024-D-2512-0001Dental Composite Resin Devices and Dental Curing Lights—Premarket Notification (510(k))…
  568. FDA-1987-N-0054-0189Letter from Warner- Lambert Company to FDA DDM
  569. FDA-1977-N-0015-0011Letter from Kleinfeld, Kaplan and Becker on behalf of Glenwood Laboratories, Inc.
  570. FDA-2016-S-0024-1854NBTY - Cinnamon supplements - Supports sugar metabolism
  571. FDA-2023-H-4031-0001Complaint
  572. FDA-2016-N-3389-0446Appendix III: Letter from Health Canada regarding Gum Acacia as Dietary Fiber re: Comment…
  573. FDA-2022-P-3200-0001Citizen Petition from Pet Schooled
  574. FDA-1975-N-0014-0013Animal Food or Feed; Prohibited Substances - Notice of Final Rule (NFR1)
  575. FDA-2016-E-2530-0002Letter from U.S. Patent and Trademark Office
  576. FDA-2021-V-1249-0003Variance Approval Letter from FDA CDRH to LEFT-HAND LASER LLC
  577. FDA-2017-D-4764-0005Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for…
  578. FDA-2025-S-0024-07112025-000807 - Szio Inc. - Ferosom Forte Caps - Helps to form red blood cells, tiredness…
  579. FDA-1997-S-0006-0438HFS-456 to Rexall Sundown Inc - Letter - Let 147
  580. FDA-2016-D-1270-0010Request for Extension from Valerie Lis
  581. FDA-2019-H-5873-0001Complaint
  582. FDA-2020-H-1150-0001Complaint
  583. FDA-2025-N-1157-0019Presentation Video from Ed Hisscock
  584. FDA-2025-P-5433-0004Attachment 2 Proposed Generic Product Pack Insert
  585. FDA-2006-P-0204-0001FDA/DDM to Boehringer Ingelheim Pharmaceuticals, Inc.
  586. FDA-2011-S-0932-0900NBTY, Inc. (H-E-B Cat's Claw Supplements)
  587. FDA-1986-P-0047-0001Citizens Petition from Lederle Laboratories
  588. FDA-2016-S-0024-2056TK Supplements Inc - Super Prostaflow + ™ - Supports prostate health
  589. FDA-2016-D-0545-0015Reference 12 - First report of autochthonous transmission of Zika virus in Brazil…
  590. FDA-2014-N-1030-0022Agency Information Collection Activities; Announcement of Office of Management and Budget…
  591. FDA-2023-N-0918-0003Agency Information Collection Activities; Announcement of Office of Management and Budget…
  592. FDA-2025-H-3889-0001Complaint
  593. FDA-2015-S-0024-0095NBTY Inc - CoQ10 supplements - Heart health
  594. FDA-2013-S-0024-0615Nordic Naturals (ProDHA 1000) - Letter
  595. FDA-2022-H-1584-0001Complaint
  596. FDA-2017-N-7022-0001Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket…
  597. FDA-2022-N-2390-0346Exhibit 24 - Type B EOP2 Meeting Minutes (June 26, 2009)
  598. FDA-2011-S-0932-1029NBTY, Inc. (CVS Daily Multiple for Women 50+ Supplements)
  599. FDA-2016-E-1882-0004Letter from U.S. Patent and Trademark Office to CDER
  600. FDA-2021-N-0665-0002George Kuiper: Final Debarment Order
  601. FDA-1997-N-0212-0002Notice of Withdrawal Letter from FDA DDM to Babineaux's Veterinary Products, Inc. et al
  602. FDA-2004-P-0467-0025Reference 14: DHHS, Results of National Oral Health Survey Results (press release)…
  603. FDA-2014-N-1051-0244243 7694105 Diary Subject R4085_Redacted
  604. FDA-2021-V-1204-0003Variance Approval Letter from FDA CDRH to Ryan Correll
  605. FDA-2015-H-4258-0002Complaint
  606. FDA-2019-E-3162-0002Patent Extension Application from Covington & Burling LLP (on behalf of Neorocrine…
  607. FDA-2017-S-0024-09682017001143 - Jarrow Formulas, Inc. - Jarrow Formulas® Preg-Natal® Dietary - provides…
  608. FDA-2019-N-4060-0006Footnote 9 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in…
  609. FDA-2015-S-0024-3376Natural Organics, Inc. - Adrenal Support - Nutritional Support for Healthy Adrenal…
  610. FDA-2025-P-5272-0006Suitability Petition Amendment from Athyna Pharma LLC
  611. FDA-2021-V-0187-0001Variance Application from Thomas Ellis
  612. FDA-2024-H-1682-0001Complaint
  613. FDA-2019-S-0024-01552019002134-SmartyPants, Inc -MULTIPLE CLAIMS (3)
  614. FDA-1998-P-0669-0005Withdrawal from Association for Dressing & Sauces
  615. FDA-2016-S-0024-0554Waterpure, Inc. d.b.a Purity Products- MuffinStop Appetite Controller - Appetite…
  616. FDA-2014-D-1814-0071Reference 40 Assessing the effectiveness of whole blood derived platelets stored as a pool…
  617. FDA-2010-N-0002-0003Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and…
  618. FDA-2019-E-3165-0004Letter from FDA CDER to U.S. Patent and Trademark Office
  619. FDA-2019-V-5533-0002Acknowledgment Letter from FDA DMS to Kvant Laser Compliance LLC
  620. FDA-2013-N-0013-0165Record of Outreach Sessions from FDA CFSAN on FDA Proposed Rules GMA
  621. FDA-1997-M-0339-0002Summary of Safety and Effectiveness Data re: Avanta Orthopaedics Corporation
  622. FDA-1987-N-0054-0064Exhibit G-138.36 re: Disclosure of Data and Information from FDA/CDER (Vol 55 of 109)
  623. FDA-2001-P-0321-0002Acknowledgement Letter from FDA DMB to the Washington Legal Foundation
  624. FDA-2023-H-4474-0001Complaint
  625. FDA-2016-S-0024-1385Renew Life Formulas, Inc - Digest Smart® Adult 50+ Care - For Occasional Gas, Bloating…
  626. FDA-2021-N-0555-0012Reference 22 - PSAPs v Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices…
  627. FDA-2023-N-3902-1676Comment from Lee Tilson
  628. FDA-2019-V-1965-0004Variance Application Renewal form Sojo Inc dba FadeUp Design Group
  629. FDA-2016-V-0615-0005Letter from FDA CDRH to Live Light Inc.
  630. FDA-2009-S-0607-0296Perrigo - Vitasmart Multi-Vitamins and Meijer Women's Formula - Help Keep You Strong and…
  631. FDA-2018-S-0024-03042018-2081 Solstice Medicine Co.- Tong Feng Ding Capsule Herbal Supplement- Supports Joint…
  632. FDA-2011-N-0002-0098Meetings: Vaccines and Related Biological Products Advisory Committee
  633. FDA-2015-H-0306-0001Complaint
  634. FDA-2023-S-0024-07102023-001470 - NSI GROUP LLC - SIMPLE TRUTH, COLLAGEN PEPTIDES - HELPS SUPPORT SKIN…
  635. FDA-2003-V-0136-0001HFA-305 to DBA Posh Nightclub Lorenzo Entertainment
  636. FDA-2024-S-0024-03092024-000967 - Nordic Naturals - Nordic Naturals Nordic Flora Prebiotic Fiber Blend…
  637. FDA-1978-N-0899-0037Citizen Petition from Robert D. Dowling Redacted
  638. FDA-2010-E-0483-0003Elan Pharma International Ltd. (Covington & Burling LLP) - Patent Extension Application
  639. FDA-2005-N-0304-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Focus…
  640. FDA-2015-P-0389-0004Annex 2
  641. FDA-2021-V-0451-0001Variance Request from Waygate Technologies USA, LP
  642. FDA-2019-H-2253-0001Complaint
  643. FDA-1986-P-0010-0002FDA
  644. FDA-2010-S-0664-0283Vitacost.com, Inc. - NSI Synergy Platinum Multi-Vitamin Version 4 - Supports…
  645. FDA-2009-N-0665-0071New Animal Drugs; Change of Sponsor; Ketamine - Final Rule
  646. FDA-2012-P-0298-0010Joseph Dedvukaj Firm, P.C. (on Behalf of Arena Pharmaceuticals, Inc. et al) - Supplement
  647. FDA-2024-E-0478-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  648. FDA-2017-H-2633-0001CMP Complaint Issued to Min Weng d/b/a China Moon
  649. FDA-2009-P-0595-0007Attachment B - "Meridia (Sibutramine) United States Food and Drug Administration…
  650. FDA-2018-H-2256-0001Complaint
  651. FDA-2022-E-2097-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  652. FDA-2011-N-0921-18969QAR _Reference 144_MacIntire-2011-Sprout Production Warning Letter re Standards for the…
  653. FDA-2015-H-4189-0001CTP CMP Case re Whitmire Food Mart, LLC d/b/a Whitmire Food Mart
  654. FDA-2002-N-0153-0123FDA Outreach Meeting held in Maryland
  655. FDA-2025-H-0661-0001Complaint
  656. FDA-2016-N-0001-0130Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee…
  657. FDA-1996-V-0501-0014Acknowledgment Letter from FDA CDRH to GE CUrrent
  658. FDA-2024-H-0397-0001Complaint
  659. FDA-1980-N-0038-0453Certificate of Service
  660. FDA-2023-H-3401-0001Complaint
  661. FDA-2005-H-0506-0076FDA/CDRH/OGC
  662. FDA-2008-S-0664-0090NDI 455 - 70% Toona Sinesis, 30% Heracleum lanatum - SUPPORTING & RELATED MATERIALS
  663. FDA-2006-P-0083-0001Letter from FDA CDER to Camargo Pharmaceutical Services, LLC
  664. FDA-2016-E-0463-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  665. FDA-2017-N-3068-0003The Voice of the Patient Hereditary Angioedema
  666. FDA-2006-N-0414-0001FDA
  667. FDA-2015-S-0024-2325NBTY, Inc. - Fish Oil - Heart, joint & skin health
  668. FDA-2019-S-0024-08892019-002680 - Nu Skin Enterpriese- Pharmanex kids, Mighty Minds- Supports brain health and…
  669. FDA-1999-N-0098-0004Guidance for Industry - Reports on the Status of Postmarketing Study Commitments…
  670. FDA-2024-V-5102-0002Acknowledgment Letter from FDA DMB to Cam Reid
  671. FDA-2021-S-0024-0027SFC2021-000041 Brilliant Science LLC - Brilliant Science, LLC, Brilliant Enhance…
  672. FDA-2021-P-0885-0002Acknowledgment Letter from FDA DMS to Zydus Pharmaceuticals (USA) Inc.
  673. FDA-2013-S-0023-0100Meditech/FerroCare (Bovine Hemoglobin Powder [OptiFer]) - Report 798
  674. FDA-2019-P-0076-0002Acknowledgement Letter from FDA DDM to Unichem Pharmaceuticals (USA), Inc.
  675. FDA-2016-S-0024-0677OLLY PBC - Hello Sunshine Vitamin D3 (also marketed as Simply Vitamin D3) - supporting…
  676. FDA-2018-N-3552-0008006 - Reference 5 - SAMHSA - 2016 National Survey on Drug Use and Health Detailed Tables
  677. FDA-2021-S-0024-14092021-3312 Piping Rock Health Products - MULTIPLE CLAIMS (5)
  678. FDA-1975-N-0355-0025Answer from FDA/CDER to Hamel, Park, McCabe & Saunders
  679. FDA-2020-H-0208-0001Complaint
  680. FDA-2014-N-1051-0513512 7694105 RDC CRF Subject R4072_Redacted
  681. FDA-2009-S-0607-0447Perrigo - HEALTHsense Dairy Aid - Helps Prevent the Gas, Bloating or Diarrhea that Many…
  682. FDA-2022-E-2244-0005Determination of Regulatory Review Period for Purposes of Patent Extension; WINLEVI
  683. FDA-2010-S-0664-0520EuroPharma, Inc. - Freeze Dried Cherry Fruit Extract - Promotes Healthy Uric Acid Levels
  684. FDA-2009-D-0343-0001International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and…
  685. FDA-2004-D-0439-0005Guideline
  686. FDA-2024-E-0194-0009Letter to U. S. Patent and Trademark Office
  687. FDA-2024-V-0473-0002Acknowledgment Letter from FDA DMS to Southeastern University
  688. FDA-2010-D-0246-0001Residual Drug in Transdermal and Related Drug Delivery Systems; Availability
  689. FDA-2015-H-3911-0001CTP CMP Case re Whitey’s South Beach Outfitter, LLC d/b/a Whitey’s Bait and Tackle
  690. FDA-2016-N-3120-0550ANDA 091695 Methylphenidate TSI 1349 Summary
  691. FDA-2022-S-0023-0065NDI 1266 - ALPHA-GLYCERYL PHOSPHORYL CHOLINE (A-GPC) - Original NDI Notification
  692. FDA-2011-N-0915-0002Agency Information Collection Activities; Submissions for Office Management and Budget…
  693. FDA-2010-P-0170-0006FDA/CVM to Lannett Comany, Inc. - Petition Denial
  694. FDA-2015-H-4126-0001CTP CMP Case re Yagnesh Thanki d/b/a King’s Convenience
  695. FDA-2018-H-3021-0001Complaint
  696. FDA-2018-D-4524-0002S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines…
  697. FDA-2004-E-0266-0006FDA/CDER to the U.S. Patent and Trademark Office - Letter
  698. FDA-2017-P-3989-0002Acknowledgement Letter from FDA DDM to Lachman Consultant Services, Inc
  699. FDA-2010-S-0664-2287Perrigo - H-E-B Complete - Immune Support
  700. FDA-2018-H-2717-0001Complaint
  701. FDA-2024-S-0024-05972024-001423 - Lovita Foods International Corporation - Lutein; Bilberry Extract; Black…
  702. FDA-2013-V-1629-0003Variance Approval from FDA CDRH to Journey Church
  703. FDA-2018-S-0024-03132018-2211 Country Life- MULTIPLE CLAIMS (7)
  704. FDA-2000-P-0212-0002FDA/CDER to New Jersey General Assembly
  705. FDA-2023-P-2583-0006Appendix 3 - Patent Certification Statement RE Suitability Petition from Norbrook…
  706. FDA-1996-N-0051-0015Background Information
  707. FDA-2016-N-0124-037616-5-3-representative-chromatograms
  708. FDA-2023-S-0024-02492023-000281 - DONG-E E-JIAO HEALTH PRODUCTION CORPORATION LIMITED- DEEJ,Taohuaji Ejiao…
  709. FDA-2022-H-2655-0001Complaint
  710. FDA-2000-S-1575-0035NDI 68 - Diosmin from Nutratech, Inc
  711. FDA-2022-V-0533-0002Acknowledgment Letter from FDA DMS to Water St. Pub
  712. FDA-2013-P-1612-0014Acknowledgement Letter from FDA/DDM to Edith Hoechst
  713. FDA-2010-S-0664-2541Genexis - Colostrum Transfer Factor - Enhance Immune System Response
  714. FDA-2013-E-1691-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  715. FDA-2020-P-2237-0001Citizen Petition from Dr. S. Albert Edwards
  716. FDA-2014-N-1051-0280279 7694105 Diary Subject R4121_Redacted
  717. FDA-2016-H-3084-0001Complaint
  718. FDA-2016-V-0144-0009Variance Supplement Request from Barco NV
  719. FDA-2023-N-2727-0001Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
  720. FDA-2011-F-0171-0005Reference 2 - "Food and Drug Administration, Food Labeling Guide" - [Food Labeling; Food…
  721. FDA-2001-D-0129-0002Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental…
  722. FDA-2014-N-0189-6179Request for Extension from Anonymous
  723. FDA-2014-E-2363-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  724. FDA-2024-H-3848-0001Complaint
  725. FDA-2024-E-1284-0005Letter from U.S. Patent and Trademark Office to FDA CDER
  726. FDA-2012-S-1144-0894Waterpure, Inc., d.b.a Purity Products - ULTIMATE H.A. FORMULA - Supports; helps maintain…
  727. FDA-2011-S-0932-2430International Vitamin Corporation - Trunature ® Lutein and Zeaxanthin - Healthy vision
  728. FDA-2021-S-0024-00322021-000032- EuroPharma Terry Naturally EuroMedica - Terry Naturally, Andrographis EP80…
  729. FDA-2025-S-0024-07492025-000846 - Organika Health Products Inc - Göutrin® Vegetarian Capsules - uric acid…
  730. FDA-2016-N-3818-002530 Reference 29 Design, Evaluation and Pharmacokinetic Study of Mucoadhesive Buccal…
  731. FDA-2022-S-0024-04642022-000464 - Santa Cruz Nutritionals - Equate Adult Miltivitamin + Immune Gummies 120ct…
  732. FDA-2025-S-0024-03922025-000476 - PRZ NOW LLC - Prozis Energy Electrolytes - Hydration and electrolyte boost
  733. FDA-2015-S-0024-1156Perrigo - Equate™ - Complete Multivitamin - Brain Health
  734. FDA-2013-V-0624-0003FDA/CDRH to Merritt Productions - Approval for Variance
  735. FDA-1975-N-0012-0001Draft FRN - Topical Antimicrobial Drug Products for Over-the Counter Human Use; Tentative…
  736. FDA-2008-P-0445-0002Acknowledgement Letter to CPT Pulp & Paper, LLC
  737. FDA-2017-P-5787-0196Reference 194 Waldstreicher_PLESS Trial_Finasteride (MK-906) Clinical Study Report…
  738. FDA-2017-H-5041-0001Complaint
  739. FDA-2014-N-2244-0316Reference 307 USDA_NASS_1999_1997 Census of Agriculture re Draft Environmental Impact…
  740. FDA-2019-S-0024-03462019002336 - Edica Group Inc - Think Tank - Helps to support cognitive health and/or brain…
  741. FDA-2020-V-2346-0002Acknowledgment Letter from FDA DMS to Jayden Romay Ruiz
  742. FDA-2025-P-0268-0002Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc
  743. FDA-2009-N-0381-0001Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment
  744. FDA-2004-S-0530-0018Annex 11: Lessons Learned from 1976 Swine Influenza Program (Draft) - [HHS - Supplement]
  745. FDA-2023-N-3902-0578Comment from Teri Endrich
  746. FDA-2012-N-1203-0003Agency Information Collection Activities; Proposed Collection; Comment Request…
  747. FDA-2013-V-0967-0001Tek-Know? - Application for Variance
  748. FDA-1997-S-0006-0191FDA/CFSAN to Davisco Foods International Inc
  749. FDA-2010-D-0431-0005Guidance for Food and Drug Administration Staff and Tobacco Retailers; Availability: Civil…
  750. FDA-2014-N-0189-6434Request for Extension from Jason Oetting
  751. FDA-2016-P-2781-0002Acknowledgement Letter from FDA DDM to Alcon Pharmaceuticals, Ltd.
  752. FDA-2002-D-0094-0033Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food…
  753. FDA-2018-E-4429-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  754. FDA-2017-P-2233-0052Interim Response from FDA to Consumers for Dental Choice
  755. FDA-2006-P-0025-0014Sanofi-aventis U.S LLC - Appendix B - Supplemental Declaration of Nichola s P. Farrell…
  756. FDA-1997-S-0039-0561Gumtech International Inc., (Jack LaLanne's Ginseng Gum) LET317 - Letter
  757. FDA-1993-F-0015-0001Irradiation in the Production, Processing, and Handling of Food; Final rule
  758. FDA-2021-V-0263-0002Acknowledgment Letter from FDA DMS to Blue Lotus Society
  759. FDA-2010-S-0664-1365Perrigo - GoodSense Century Mature - Promote the Health of Heart, Eyes and Bones
  760. FDA-2008-N-0038-0017Pediatric Advisory Committee; Amendment of Notice
  761. FDA-2023-V-4006-0002Acknowledgment Letter from FDA DMS to Mark Carey
  762. FDA-2024-S-0023-0053NDI 1349 - TetraSOL from Microphyt
  763. FDA-2007-D-0369-1973PSG_202067 - Draft Guidance on Clobazam
  764. FDA-2019-Q-0806-0250Supplemental Petition 3-3-21
  765. FDA-2023-V-4369-0002Acknowledgment Letter from FDA DMS to Laseronics
  766. FDA-2019-P-5791-0004Attachment 2- Federal Register Notice that Azo Gantanol and Azo Gantrisin were not…
  767. FDA-2015-D-0838-0017Reference 3 - Panel Review of Premarket Approval Applications #P91-2 (blue book memo) re…
  768. FDA-2024-H-3883-0001Complaint
  769. FDA-2023-D-3134-0017Request for Extension from Cardinal Health
  770. FDA-1995-P-0142-0006Calorie Control Council - Supplement
  771. FDA-2007-N-0387-0004Background Material
  772. FDA-2016-S-0024-1853NBTY - Vitamin E supplements - Supports immune and antioxidant health
  773. FDA-2003-N-0451-0004Agency Information Collection Activities; Announcement of Office of Management and Budget…
  774. FDA-2015-N-3579-0001Using Technologies and Innovative Methods To Conduct Food and Drug…
  775. FDA-2023-H-0048-0001Complaint
  776. FDA-2019-H-1754-0001Complaint
  777. FDA-2022-H-1430-0001Complaint
  778. FDA-2016-P-2559-0017Exhibit 13 Terri Adamchick v. MECTA Corp re Citizen Petition from Emord and Associates…
  779. FDA-2003-N-0389-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
  780. FDA-1997-S-0039-2745Perrigo - HEALTHsense - One Daily - Calcium, Magnesium and Vitamin C support normal blood…
  781. FDA-1997-S-0006-1822Courtesy letter and related material from CFSAN to Steeped Fine Losse Teas & Accessories…
  782. FDA-1976-N-0027-0025Letter from FDA/CDER to Arnold & Porter, LLP
  783. FDA-2009-S-0607-1642Perrigo Company of South Carolina - CareOne®-Multiple Vitamins - Complete multivitamin for…
  784. FDA-2005-S-0518-0121NDI 295 - Heracleum lanatum - Original NDI Notification
  785. FDA-2025-E-0923-0006Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
  786. FDA-2015-S-0024-2889NBTY, Inc. - Iron - Helps maintain iron-rich blood
  787. FDA-2015-S-0024-1961NBTY - Herbal Laxative supplements - Help ease occasional constipation and promote…
  788. FDA-1984-G-0019-0068Letter from Novo Laboratories, Inc.
  789. FDA-2019-H-2868-0001Complaint
  790. FDA-2014-N-1051-0136134 7694105 Diary Subject R3006_Redacted
  791. FDA-2014-Q-1146-0014Appendix XII RCT Data Extraction re Petition for a Qualified Health Claim from Global…
  792. FDA-2013-S-0024-1080NBTY Inc. - Acai - Antioxidant Support
  793. FDA-2016-E-2227-0005Determination of Regulatory Review Period for Purposes of Patent Extension; SYNERGY…
  794. FDA-2014-P-1882-0002Acknowledgement Letter From FDA DDM to Isabella Guajardo
  795. FDA-2023-N-3902-1821Comment from Jenkin and Marie Washington
  796. FDA-2018-H-4070-0001Complaint
  797. FDA-1977-P-0017-0005Letter from N. I. H./National Cancer Institute to The Cosmetic, Toiletry & Fragrance…
  798. FDA-2012-V-0615-0002Acknowledgement Letter to One Stop Laser Shop, Inc. (OSLS)
  799. FDA-2005-D-0226-0007FDA
  800. FDA-2024-E-0130-0005Determination of Regulatory Review Period for Purposes of Patent Extension; INPEFA
  801. FDA-2017-H-2588-0001CMP Complaint Issued to 87th Mobil Petrol, Inc. d/b/a Mobil Mart
  802. FDA-2010-N-0622-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
  803. FDA-2025-S-0024-02272025-000305 - Harmony Foods LLC - Spring Valley Extra Strength Magnesium Citrate 60ct…
  804. FDA-2017-H-6161-0001Complaint
  805. FDA-2003-N-0103-0010GUIDANCE
  806. FDA-2016-P-2375-0001Citizen Petition from AKORN Specialty Generics
  807. FDA-2017-R-3855-0001NTSO Complaint Issued to Baydoun Brothers, Inc., d/b/a Shell Food Mart
  808. FDA-2011-S-0932-2212NBTY, Inc. - Blood Sugar Specifics - Helps Maintain Blood Sugar Levels
  809. FDA-2008-N-0341-0001Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing…
  810. FDA-2003-D-0029-0001FDA
  811. FDA-1997-S-0039-1463NOW Foods - Now AlphaSorb-C contains the Vitamin C metabolite, Threonic Acid, which has…
  812. FDA-2004-D-0500-0004Draft Guidance for Industry Brief Summary: Disclosing Risk Information in…
  813. FDA-2025-E-0492-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  814. FDA-2019-H-4111-0001Complaint
  815. FDA-1996-S-0115-0002Letter from Pharmaceutical Research and Manufacturer of America to FDA Office of…
  816. FDA-1984-P-0360-0006Exhibit 4 Letter from FDA CFSAN to Schmidt Baking Company, Inc. Nov. 8, 1984 re: Food for…
  817. FDA-2012-N-0002-0030Freedom of Information Summary NADA 141-343 Tilmicosin Phosphate and Monensin
  818. FDA-1984-G-0019-0010Letter from FDA/HFF-335 to Ad Hoc Enzyme Technical Committee
  819. FDA-2014-N-1051-0740739 7694105 Survey Subject R4049_Redacted
  820. FDA-2024-N-5471-0061Reference 59 - Dani Molecular and cellular aspects of 1996
  821. FDA-2025-P-3956-0007Anekwe, C. V., Ahn, Y. J., Bajaj, S. S., & Stanford, F. C. (2024). Pharmacotherapy causing…
  822. FDA-2012-P-0317-0002Acknowledgement Letter to Abbott Laboratories (Covington & Burling LLP)
  823. FDA-2019-S-0024-08042019002578- International Vitamin Corporation- MULTIPLE CLAIMS (2)
  824. FDA-1999-D-0060-0001Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray…
  825. FDA-2022-D-0467-0138135 HIV antiretroviral therapy and prev use in US blood donors 2020
  826. FDA-2023-N-0722-0001Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug…
  827. FDA-2025-V-0404-0001Variance Application from Energy Science Unlimited
  828. FDA-2025-P-1241-0003Interim Response Letter from FDA CDER to Kaylin Bower
  829. FDA-2011-D-0643-0002Guidance for Industry; What You Need to Know About Administrative Detention of Foods
  830. FDA-1998-D-0095-0003Guideline
  831. FDA-2020-V-0964-0002Acknowledgment Letter from FDA DMS to Hetterington Family
  832. FDA-1986-V-0037-0004FDA Center for Devices and Radiological Health to Magic Light Laser Imagery - Approval for…
  833. FDA-2023-H-3089-0001Complaint
  834. FDA-2019-V-5899-0001Variance Application from Arizona Coyotes
  835. FDA-1997-S-0039-0812Iovate Health Sciences U. S. A., Inc. - Letter
  836. FDA-2018-N-3233-0003Request for Nominations for Voting Members on a Public Advisory Committee; Technical…
  837. FDA-1987-V-0013-0020Variance Approval from FDA CDRH from Benedum Natural Science Theater
  838. FDA-2005-D-0139-0005FDA
  839. FDA-2017-P-6967-0002Acknowledgment Letter from FDA DDM to Bergstrom Nutrition
  840. FDA-2023-H-5666-0001Complaint
  841. FDA-2024-P-3479-0002Acknowledgment Letter from FDA DMS to Jingwei Pharmaceutical Company, Ltd.
  842. FDA-2018-V-3739-0001Variance Application from Home Bass Entertainment.
  843. FDA-2014-H-1437-0001Complaint
  844. FDA-2019-H-5816-0001Complaint
  845. FDA-2020-V-1744-0002Acknowledgment Letter from FDA DMS to Maple Empire Enterprise
  846. FDA-2025-S-0024-11862025-001276 - Szio Inc. - Ferosom Forte Gummies - Helps support healthy iron levels…
  847. FDA-2005-N-0037-0002Background Material
  848. FDA-2025-H-4853-0001Complaint
  849. FDA-1981-N-0012-0027HFD-514
  850. FDA-2011-P-0438-0006FDA/CDRH Response to Public Citizen Health Research Group - Partial Petition Approval and…
  851. FDA-2013-D-0744-0013Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of…
  852. FDA-2010-S-0664-2101North American Pharmacal, Inc. - D'Adamo Personalized Nutrition Live Cell A - Support…
  853. FDA-2019-H-5163-0001Complaint
  854. FDA-2012-N-0001-0018Requests for Nominations for Voting Members: Risk Communication Advisory Committee
  855. FDA-2017-H-6771-0001Complaint
  856. FDA-2024-H-3818-0001Complaint
  857. FDA-2009-S-0607-0862Perrigo - Equaline Century - Prostate & Colon Health
  858. FDA-2018-S-0024-04382018001562- International Vitamin Corporation- MULTIPLE CLAIMS (30)
  859. FDA-2018-H-4695-0001Complaint
  860. FDA-2008-N-0039-0026Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
  861. FDA-1984-N-0259-0410Memorandum of Telephone Conversation between Richard Morey (Kleinfeld, Kaplan and Becker)…
  862. FDA-2006-V-0402-0001FDA/ DDM to Bart Rocket Theatre
  863. FDA-2019-H-2933-0001Complaint
  864. FDA-2016-N-2462-0013Reference 11 FDA Drug Safety Communication re Amendments to the Regulation Regarding the…
  865. FDA-1997-S-0039-3131Nikken, Inc. - Multiple Cliams - 15
  866. FDA-2024-P-4956-0003Appendix 1 - Approved Product Labeling - HCT
  867. FDA-2021-V-0296-0001Variance Application for Wicked Smart Homes
  868. FDA-1998-C-0045-0003Withdrawal of Color Additive Petition: EMD Chemicals, Inc.
  869. FDA-2023-N-3902-1762Comment from Alliance to Prevent Restraint, Aversive Interventions, and Seclusion (APRAIS)
  870. FDA-2008-P-0442-0005Mutual Pharmaceutical Company, Inc. - Supplement Petition
  871. FDA-2025-P-2526-0044Reference 42 - International Academy of Biological Dentistry and Medicine (IABDM)’s…
  872. FDA-2007-D-0369-2361PSG_218711 - Draft Guidance on Docetaxel
  873. FDA-2008-S-0664-0085NDI 454 - Veniphlex from Propharma, Inc.
  874. FDA-2018-H-2784-0001Complaint
  875. FDA-1997-S-0006-0141HFS-800 to WTSmed Inc
  876. FDA-2016-H-2662-0001Complaint
  877. FDA-2018-H-4011-0001Complaint
  878. FDA-2018-S-0023-0022NDI 1053 - Bupleurum falcatum Linne - Reference List
  879. FDA-2009-S-0608-0014NDI 555 - Vitamin B12-SNAC from Emisphere
  880. FDA-1993-N-0013-0001FDA
  881. FDA-2000-D-0002-0002Guidance
  882. FDA-2017-S-0023-0094NDI 1030 - Phosphoric Acid Food Grade from Guangxi Fangchenggang Duolin Chemical Company…
  883. FDA-2025-P-1030-0007Final Response Letter from FDA CDER to Samson Medical Technologies, LLC
  884. FDA-2018-H-3768-0001Complaint
  885. FDA-2025-P-3956-0176Zhao, X., Liu, Q., Cao, S., Pang, J., Zhang, H., Feng, T., Deng, Y., Yao, J., & Li, H…
  886. FDA-2017-V-6666-0003Variance Approval from FDA CDRH to Organic Communication
  887. FDA-2008-N-0038-0026Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice…
  888. FDA-2014-P-1753-0004Citizen Petition From Angela A Stanton PHD
  889. FDA-2016-P-0541-0002Acknowledgement Letter from FDA DDM to Gordon Johnston Regulatory Consultants, LLC
  890. FDA-1994-N-0182-0013Denise M. Buntin, M.D. - Appearance Request
  891. FDA-2017-H-2822-0001CMP Complaint Issued to Sam N Ram, Inc. d/b/a Edgewood Liquor Grocery and Deli
  892. FDA-2015-H-4484-0001CTP CMP Case re Suzanne Wong d/b/a Pioneer Square Market and Deli
  893. FDA-2007-D-0369-1779PSG_217639-Draft Guidance on Elacestrant Dihydrochloride
  894. FDA-1998-N-0051-0173Letter from Kleinfeld, Kaplan and Becker to FDA CDER
  895. FDA-2021-V-0348-0001Variance Application from Christie Digital Systems Canada Inc.
  896. FDA-2014-N-1027-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Infant…
  897. FDA-2019-N-3325-0034Reference 9: Thompson, Michael; Kenneth Mathieson; Linda Owen; Andrew P. Damant; Roger…
  898. FDA-1997-S-0039-1354Bayer HealthCare Consumer Care - Alka-Seltzer Plus Immunity - Specially formulated to…
  899. FDA-2008-V-0503-0002Acknowledgement Letter to Victor Litz Music
  900. FDA-2014-H-1348-0001Complaint
  901. FDA-2007-P-0122-0011Federal Trade Commission
  902. FDA-2008-N-0567-0014Reference 2 - World Economic Outlook Recovery Strengthens, Remains Uneven re Designating…
  903. FDA-2020-H-1501-0001Complaint
  904. FDA-2018-S-0023-0093NDI 1076 - Agave Salmiana Sap Concentrate - Original NDI Notification
  905. FDA-2017-H-1513-0001CMP Complaint Issued to Admiral Petroleum Company d/b/a Admiral 177
  906. FDA-2003-N-0394-0010Background Information
  907. FDA-2005-D-0445-0014Reference 5 re Draft Guidance for Industry and Food and Drug Administration Staff on Class…
  908. FDA-1985-D-0044-0011GUIDANCE
  909. FDA-2011-P-0078-0003Acknowledgement Letter to Ceva Animal Health, LLC (CEVA Santé Animale)
  910. FDA-2015-V-1601-0002Acknowledgement Letter From FDA DDM to Bethel Baptist Church
  911. FDA-2025-S-0024-12172025-001308 - Atlantis Consumer Healthcare Inc - SlowMag - MUSCLE HEART (120ct, 180ct)…
  912. FDA-2022-E-0276-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  913. FDA-2019-P-5922-0003Exhibit 1- Introduction, Conclusions, and Historical BackgroundRelative to E-Cigarettes…
  914. FDA-2017-H-4397-0001CMP Complaint Issued to Underwood Convenience Stores, Inc. d/b/a Underwood Convenience…
  915. FDA-2000-N-0010-0002Prescription Drug Products; Digoxin Elixir; Extension to Obtain Marketing Approval
  916. FDA-2016-N-0002-0032New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications…
  917. FDA-2024-H-1029-0001Complaint
  918. FDA-2007-P-0343-0002Lachman Consultant Services, Inc. - Citizen Petition
  919. FDA-2019-H-3399-0001Complaint
  920. FDA-2015-S-0024-2977Perrigo - Spring Valley - promotional - Nerve & Muscle Health
  921. FDA-2024-H-4395-0001Complaint
  922. FDA-2021-V-1165-0002Acknowledgment Letter from FDA DMS to Sherwood Tabarejo
  923. FDA-1984-N-0259-0327Motion of Mead Johnson and Company to Certify Order to the Commissioner
  924. FDA-1976-N-0525-0024FDA
  925. FDA-1997-S-0006-0221FDA/CFSAN to Global Healing Center Inc
  926. FDA-2018-H-1113-0001Complaint
  927. FDA-2015-D-4021-0003Request for Extension from Personal Care Products Council and the Consumer Healthcare…
  928. FDA-2015-S-0024-1585NBTY - Daily Women's Active supplements under the H-E-B label - Supports mental and…
  929. FDA-2015-V-0370-0001Variance Application from Y Graphx
  930. FDA-2023-H-0204-0001Complaint
  931. FDA-2009-V-0250-0001Laser Devices, Inc. - Application for Variance
  932. FDA-2025-S-0024-05102025-000594 - Kaged Muscle - Kaged, Caffeine 100mg - Helps to stay alert and focus
  933. FDA-2016-D-2335-0730Request to Extend Comment Period from Herbalife International of America, Inc.
  934. FDA-1997-S-0006-1607Courtesy letter and related material from CFSAN to Pharmavite LLC
  935. FDA-1997-S-0006-1366Courtesy Letter from CFSAN to FoodState
  936. FDA-2013-V-1134-0002Acknowledgement Letter to Sonido Carismatico
  937. FDA-2007-P-0054-0002Acknowledgement Letter from FDA/DDM to Diamond Law Office LLC
  938. FDA-2005-D-0211-0044Reference
  939. FDA-2024-H-0694-0001Complaint
  940. FDA-1989-G-0391-0176References: Articles and Publication Van Soest, et al (1982)Some In Vitro and In Vivo…
  941. FDA-2014-N-0504-0001Administrative Destruction of Certain Drugs Refused Admission to the United States
  942. FDA-2007-N-0199-0036Marks, Norman
  943. FDA-2008-N-0038-0062Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs…
  944. FDA-2023-P-2339-0007Citizen Petition Response from FDA CDER to Granules India Ltd
  945. FDA-2013-D-0918-0001Draft Guidance for Industry and Staff; Availability: Applicability of Good Laboratory…
  946. FDA-2024-S-0024-00932024-000416 - Viva Naturals Inc - Supports digestive health
  947. FDA-2018-S-0024-01222018001285- International Vitamin Corporation- MULTIPLE CLAIMS (5)
  948. FDA-2001-E-0186-0002U.S. Patent and Trademark Office
  949. FDA-2007-D-0369-0308Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for…
  950. FDA-2005-P-0268-0001Acknowledgment Letter from FDA DDM to Lachman Consultant Services, Inc.
  951. FDA-1997-S-0039-2184Perrigo - Multiple claims - 2
  952. FDA-2022-H-1234-0001Complaint
  953. FDA-2016-V-3577-0001Variance Application from Amp Event Productions
  954. FDA-2009-D-0132-0015Reference 2 - "Guidance for FDA Reviewers & Sponsors: Content & Review of Chemistry…
  955. FDA-2011-V-0228-0001C&M Music Center LLC - Application for Variance
  956. FDA-2020-S-0024-04192020-000533 SmartyPants, Inc - Masters Formula Women 50+ - Support antioxidant, good…
  957. FDA-2021-N-0471-0357Reference 54 - FDA, “Environmental Studies,” August 24, 2023
  958. FDA-2015-N-0101-0616Reference 12-55 - FDA-1975-N-0012-0134 --- C38 Volume_2 of_4_Expert_Panel_Review_of…
  959. FDA-2022-H-2405-0001Complaint
  960. FDA-2016-P-2515-0026Exhibit -24 Randomlsed controlled study of effect of parathyroid hormone on vertebral-bone…
  961. FDA-2015-D-0138-0013Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA…
  962. FDA-2022-N-0002-0017New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of…
  963. FDA-2018-H-3526-0001Complaint
  964. FDA-1976-P-0383-0001FDA/DDM to A. T. Products - Acknowledgement Letter
  965. FDA-2020-N-0955-0048Petition for Stay of Action from Covington & Burling LLP
  966. FDA-2014-N-2244-0312Reference 303 USDA_NASS_2009e_2007 Census of Agriculture_Virgin Islands of the United…
  967. FDA-2014-D-0055-0600Sodium in the U.S. Food Supply for Products in 2022
  968. FDA-2018-H-4202-0001Complaint
  969. FDA-2005-D-0443-0006FDA
  970. FDA-2019-H-1234-0001Complaint
  971. FDA-2016-P-4388-0013Response Letter from FDA CDER to Dr. S. Varghese
  972. FDA-2025-N-1927-0059GRAS Notice (GRN) 1216 with amendments
  973. FDA-2013-N-1524-1806Nomination Letter Cocoa Butter Deodorized re: Comment from Fagron
  974. FDA-2016-S-0023-0121NDI 942 - Kangaroo Meat Powder - Original NDI Notification
  975. FDA-2015-E-0861-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  976. FDA-2024-V-2507-0001Variance Application from Nathaniel Wolfe
  977. FDA-2011-N-0922-0001Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls…
  978. FDA-2015-N-3403-0905Transcript of FDA Public Meeting on Modernizing the Regulatory System for Biotechnology…
  979. FDA-2017-H-6974-0001Complaint
  980. FDA-2013-N-0134-0195Tab B - FRIA - Comparison OMB original to final version
  981. FDA-1995-P-0016-0162Background Material in 94P-0390
  982. FDA-2025-P-1807-00169 - ii Moderna Inc 2019 Form 10K annual Report US Securities and Exchange…
  983. FDA-2023-H-3179-0001Complaint
  984. FDA-1977-N-0002-1853Answer Letter from FDA/Associate Commissioner for Regulatory Affairs to American Cyanamid…
  985. FDA-2002-N-0276-0001FDA
  986. FDA-2023-H-5358-0001Complaint
  987. FDA-2019-H-3719-0001Complaint
  988. FDA-2017-S-0024-07842017000947 - International Vitamin Corporation - Helps support energy metabolism and…
  989. FDA-2024-S-0024-09242024-001796 - FM WORLD SP Z O O - FONTAINAVIE BODY & MIND FIT LINE GUMMIES- supports the…
  990. FDA-1980-N-0049-0088Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
  991. FDA-2020-S-0024-03212020-000423 Nexgen Pharma, Inc- 1 - MULTIPLE CLAIMS (2)
  992. FDA-2010-S-0664-1701North American Pharmacal, Inc. - Deflect B - Support the Body's Immune System and…
  993. FDA-2014-N-0189-3205Request for Extension from Anonymous
  994. FDA-1978-N-0021-0011Letter from FDA/CDER
  995. FDA-2021-V-0466-0003Variance Approval Letter from FDA CDRH to Koma Productionz
  996. FDA-2011-S-0932-0486Letter from NBTY, Inc.
  997. FDA-2019-H-3434-0001Complaint
  998. FDA-2010-V-0187-0002Acknowledgement Letter to Laser Rific Ltd.
  999. FDA-2012-S-1144-0520Vijosa Laboratorios (Neurocampolon Energy) - Letter
  1000. FDA-2021-P-1248-0001Citizen Petition from Lyne Laboratories, Inc

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Source: Regulations.gov (U.S. General Services Administration eRulemaking Program)