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Regulations.gov documents

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Every Regulations.gov document record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. FDA-2012-S-1144-0291EuroPharma, Inc. - CuraMax - Supports healthy cell growth & neurological health
  2. FDA-1997-S-0006-1664Courtesy letter and related material from CFSAN to Beijing Kingbird Pharmaceutical…
  3. FDA-2015-S-0024-2468Lang Pharma Nutrition, Inc. - CVS Satin Collection Biotin 5000 mcg - Hair, Skin and Nail…
  4. FDA-2017-H-5098-0001Complaint
  5. FDA-2019-H-4597-0001Complaint
  6. FDA-2025-S-0024-08172025-000917 - Pharmavite LLC - Nature Made Zero Sugar Magnesium Citrate Gummies - Supports…
  7. FDA-2024-H-2340-0001Complaint
  8. FDA-2014-E-0072-0007Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA
  9. FDA-1975-N-0012-0397FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
  10. FDA-2019-S-0024-01312019002108-Goop, Inc.- Goop Chews - Nerd Alert- improving scores on tests of memory…
  11. FDA-2023-N-3902-0581Comment from Sara Dyer
  12. FDA-2014-N-0189-5811Request for Extension from Anonymous
  13. FDA-2013-N-1524-2051Nomination Letter Methylprednisolone re: Comment from Fagron
  14. FDA-2007-P-0406-0006Sandoz Inc. - Withdrawal of Petition
  15. FDA-2020-S-0024-07112020-000867 NOW Foods - Lucky Vitamin, Alpha Lipoic Acid 600 mg - Support cardiovascular…
  16. FDA-2016-P-1286-0006Response from Lachman Consultant Services
  17. FDA-2014-S-0024-0589Bioterra Herbs (Sleep) - Letter
  18. FDA-2018-N-4626-0658Nomination from Wedgewood Pharmacy
  19. FDA-2021-P-0529-0002Acknowledgment Letter from FDA DMS to SIRI & GLIMSTAD LLP on behalf of Informed Consent…
  20. FDA-2022-D-0465-0001Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant…
  21. FDA-2014-H-0693-0001Complaint
  22. FDA-2011-P-0725-0001International Contrast Ultrasound Society (ICUS) Steven Feinstein, et al - Citizen…
  23. FDA-2023-N-3007-0001Agency Information Collection Activities; Proposed Collection; Comment Request…
  24. FDA-2014-N-0189-3534Request for Extension from Anonymous
  25. FDA-2014-N-0504-0015Appendix A2 - Harel, et al, JAMA Internal Medicine Administrative Destruction of Certain…
  26. FDA-2023-E-2391-0003Requirement for Information from U.S. Patent and Trademark Office to Mr. John Burr
  27. FDA-2012-S-1144-2536Doctor's Best, Inc. - Best Tocotrienols - Powerfully supports cardiovascular wellness
  28. FDA-2023-P-0092-0004Attachment 2 RE Suitability Petition from Felix Pharmaceuticals Pvt. Ltd.
  29. FDA-2014-M-0875-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  30. FDA-2022-S-0024-08292022-000854 - Wild Nutrition- MULTIPLE CLAIMS (8)
  31. FDA-1991-N-0025-0005BACKGROUND MATERIAL
  32. FDA-2021-V-0781-0001Variance Application from Lou Savarese
  33. FDA-2025-H-0925-0001Complaint
  34. FDA-2025-P-2487-0006Attachment 4 - Diclofenac Potassium Tablets Label
  35. FDA-2011-S-0932-2262International Vitamin Corporation - Extra Strength Glucosamine Chondroitin - Nourishes…
  36. FDA-2025-H-2064-0001Complaint
  37. FDA-2021-E-0379-0003Letter to U S Patent and Trademark Office
  38. FDA-2015-S-0024-0793Perrigo Company of South Carolina - H-E-B® - Glucosamine Chondroitin Complex - Helps…
  39. FDA-2016-H-4315-0001Complaint
  40. FDA-2023-P-3942-0004Exhibit 2 re: Citizen Petition from Jonathan H. Bari on behalf of Celiac Journey
  41. FDA-2023-H-0890-0001Complaint
  42. FDA-2009-E-0169-0003FDA/CDER to the U.S. Patent and Trademark Office - Letter
  43. FDA-2023-V-4012-0003Variance Approval from FDA CDRH to TMF Center Inc
  44. FDA-2023-N-3902-1775Comment from Ivor Weiner
  45. FDA-2011-D-0398-0008Guidance for Industry; Questions and Answers Regarding Final Rule: Prevention of…
  46. FDA-2020-S-0024-02282020-000314 Santa Cruz Nutritionals - CVS, Airshield Dietary Supplement - Supports immune…
  47. FDA-2020-E-2023-0006Patent Term Extension Approval letter from FDA CDER
  48. FDA-2018-N-4626-0582Nomination from Covetrus
  49. FDA-2024-S-0024-00522024-000249 - OLLY PBC - OLLY Mellow Buddies Brainy L'OLLY Pops - Supports a Calm Mood and…
  50. FDA-2022-H-0971-0001Complaint
  51. FDA-2016-N-2066-0006Agency Information Collection Activities; Submission for Office of Management and Budget…
  52. FDA-2022-S-0024-01732022-000156 - APTECH AMERICA CORP - MOMSTAMIN HMO CHEWABLES ORANGE - support your…
  53. FDA-2014-N-0189-5129Request for Extension from Anonymous
  54. FDA-2007-P-0238-0001FDA/DDM to Fuerst, Humphrey, Ittleman, PL
  55. FDA-2010-N-0088-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Sample…
  56. FDA-2018-P-3076-0003Interim Response Letter from FDA CDER to Dr. Joseph Purita
  57. FDA-2017-S-0024-08432017001011 - FoodState - (INNATE) GTF Chromium - helps to maintain already healthy blood…
  58. FDA-2023-V-5167-0003Variance Approval Letter from FDA CDRH to Joe Griffith
  59. FDA-2017-H-6030-0001Complaint
  60. FDA-2024-N-4754-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Financial…
  61. FDA-2018-H-4254-0001Complaint
  62. FDA-2019-S-0024-06702019-3396 FoodScience Corporation -Enztlament Kids - Claims gluten free, no artificial…
  63. FDA-2024-S-0023-0062NDI 1353 - Nunaezone - Original NDI Notification
  64. FDA-2020-P-0599-0004Response letter from FDA CDER to Romark Laboratories, L.C.
  65. FDA-2012-S-1144-2539Perrigo Company of South Carolina - Walgreens — A thru Z Select - Calcium & vitamin D help…
  66. FDA-1980-N-0066-0047Answer Letter from FDA to Comment from the Honorable Tom Lewis,, et al, United States…
  67. FDA-2022-E-0443-0004Notice of Final Determination
  68. FDA-2006-P-0014-0001Acknowledgement Letter from FDA CDER to Paddock Laboratories
  69. FDA-2011-E-0141-0003FDA/CDER to U.S. Patent and Trademark Office - Letter
  70. FDA-2007-D-0369-1257PSG_019487 - Draft Guidance on Loperamide Hydrochloride
  71. FDA-1979-F-0037-0002Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers; Antioxidants and/or…
  72. FDA-2022-P-3046-0005Attachment-3 RE: Suitability Petition from Regcon Solutions
  73. FDA-2009-V-0035-0001Wood Violins - Application for Variance
  74. FDA-2009-P-0367-0005Acknowledgement Letter to PharmaForce, Inc.
  75. FDA-2015-V-3460-0001Variance Application from All Access Production Company
  76. FDA-2022-V-3374-0001Variance Application from Anthony Risko
  77. FDA-2018-P-1469-0002Acknowledgment Letter from FDA DDM to Epstein Becker & Green, P.C.
  78. FDA-2025-S-0024-09742025-001054 - Harmony Foods LLC - Up & Up Women's Multivitamin Gummies 250ct - Energy…
  79. FDA-2025-S-0024-10592025-001145 - Gaia Herbs Inc - Gaia Herbs, Kava Root 1 fl oz Herbal Supplement - Promotes…
  80. FDA-2018-H-0567-0001Complaint
  81. FDA-2019-H-2493-0001Complaint
  82. FDA-2020-R-1670-0001Complaint
  83. FDA-2001-Q-0320-0005Central Soya Company - Supplement
  84. FDA-2009-S-0607-0319PuraPharm - Di Long & Bie Jia & Yin Chai Hui & Zhen Zhu Mu & Tu Bie Chong & Gui Jia & Tian…
  85. FDA-2023-V-0279-0003Variance Approval Letter from FDA CDRH to 5th Dimension
  86. FDA-2024-S-0024-08912024-001766 - Lovita Foods International Corporation - Lovita Vitamin B2, Time-Released…
  87. FDA-2010-N-0010-0005Change of Address; Abbreviated New Drug Applications; Technical Amendment
  88. FDA-2021-S-0024-07242021-001066 - Nutranext- Rainbow Light, Men's Multivitamin for Performance Energy…
  89. FDA-2017-H-3689-0001CMP Complaint Issued to Riskit Inc. d/b/a Mr. Shortstop 5
  90. FDA-2020-P-2013-0003Withdrawal from Lachman Consultant Services
  91. FDA-2003-P-0351-0002Acknowledgement Letter to Wyeth Pharmaceuticals [Covington and Burling]
  92. FDA-2023-N-3902-1179Comment from Sandra HIllman
  93. FDA-2023-V-2200-0003Variance Approval Letter from FDA CDRH to Matthew Huston
  94. FDA-2011-S-0932-2678NBTY, Inc. - Melatonin - Sleep Support
  95. FDA-2015-H-0351-0001Complaint
  96. FDA-1977-N-0002-1288Answer Letter from FDA/Office of Legislative Services to Honorable Butler Derrick, House…
  97. FDA-1977-N-0002-1079Answer Letter from FDA/Office of Legislative Services to Honorable Clifford P. Case…
  98. FDA-2018-P-1740-0005Amended Citizen Petition from Provetica Animal Health LLC
  99. FDA-2023-H-1879-0001Complaint
  100. FDA-2019-D-4843-0001Soft (Hydrophilic) Daily Wear Contact Lenses—Performance Criteria for Safety and…
  101. FDA-2017-H-3635-0001CMP Complaint Issued to Salcedo Grocery Inc. d/b/a Church Lane Food Market
  102. FDA-2016-E-2502-0005Letter from U.S. Patent and Trademark Office to CDER
  103. FDA-2013-V-1284-0005Variance Renewal Approval Letter from FDA CDRH to Any Excuse for a Party Inc.
  104. FDA-2016-N-3118-0012Letter granting Mallinckrodt's request for an extension
  105. FDA-2014-N-0053-0080PRIA Reference 13 - CDC 2010 - Multistate outbreak of human Salmonella Enteritidis…
  106. FDA-2024-D-1613-0002Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry
  107. FDA-2025-H-4033-0001Complaint
  108. FDA-2010-S-0664-2288Perrigo - H-E-B Complete - Antioxidants help support immune function
  109. FDA-2018-S-0024-04722018001605- FoodState- (MegaFood) Vegan B12- support healthy blood cell formation
  110. FDA-2016-N-3464-0013Reference 11 - FDA Supplemental Review of Topical Tranilast, April 25, 2016
  111. FDA-2018-S-0024-00202018-591 Country Life - MULTIPLE CLAIMS (5)
  112. FDA-2025-E-5270-0002Patent Extension Application from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (on…
  113. FDA-2010-S-0664-1932Premier Research Labs - Multi-Immune, B1-ND, B2-ND, B6-ND & Poptosin
  114. FDA-2005-P-0319-0007Exhibit 8 - "Results of Analysis" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath &…
  115. FDA-2020-N-2029-0217Procedural Team Memo for Makena June 2022
  116. FDA-2025-P-4282-0001Citizen Petition from Gilbert Honigfeld
  117. FDA-1982-P-0018-0257Background Material
  118. FDA-2020-E-2039-0006Determination of Regulatory Review Period for Purposes of Patent Extension; MAYZENT
  119. FDA-2020-S-0024-02582020-000348 GlaxoSmithKline Consumer Healthcare- MULTIPLE CLAIMS (4)
  120. FDA-2015-H-4502-0001CTP CMP Case re Gregory N. Melges d/b/a Mel’s Sport Shop
  121. FDA-2019-N-2698-0001Notice of data availability and announcement of open public comment period; pediatric…
  122. FDA-2011-F-0171-0196Reference 4 - Memo to File. Correspondence with Eric Dell of the National Automatic…
  123. FDA-2024-H-3996-0001Complaint
  124. FDA-2016-N-0736-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking…
  125. FDA-1993-P-0060-0003Letter from CVM to DDM to Close Docket
  126. FDA-2007-N-0387-0006Background Material
  127. FDA-1997-S-0039-2365Perrigo - CareOne - CENTURY - Vitamin D & Calcium to help support calcium absorption and…
  128. FDA-2022-S-0024-10122022-001051 - Welle North America Inc. - 1 - WelleCo The Clarity Elixir - Supports mental…
  129. FDA-2024-H-4175-0001Complaint
  130. FDA-2009-S-0607-0798Perrigo - Vitasmart Calcium - Bone Health
  131. FDA-2002-P-0364-0002Citizen Petition Denial Response from FDA CDER to the American Association of Pro Life…
  132. FDA-2010-N-0117-0005Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
  133. FDA-2014-N-0189-8208Request for Extension from Joe
  134. FDA-2025-V-5006-0002Acknowledgment Letter from FDA DMB to Layza Events, LLC
  135. FDA-2019-S-0024-05502019-1950 Princess House Inc.- Multiple Claims (2)
  136. FDA-1981-N-0083-0046FDA Response to Dr. Donald Stevenson - Letter
  137. FDA-2010-S-0664-0399Perrigo - Equate Calcium - For Bone and Colon Health
  138. FDA-2003-E-0262-0003HFD-005 to US Patent and Trademark Office
  139. FDA-2007-D-0369-2106PSG_216579 - Draft Guidance on Budesonide; Formoterol fumarate
  140. FDA-2012-V-1190-0001UHSPAC - Application for Variance
  141. FDA-2025-V-0215-0002Variance Acknowledgment Letter from FDA DMB to DJ Russell
  142. FDA-1997-S-0540-0006NDI 8 - Cordia boissieri, Gnaphalium berlandieri - SUPORTING & RELATED MATERIAL
  143. FDA-2021-S-0024-09472021-001190 - Swanson Health Products 11658148874 - Swanson Health Products, Multi + DHA…
  144. FDA-2022-V-0404-0002Acknowledgment Letter from FDA DMS to Justin Gregg
  145. FDA-2017-H-2020-0001CMP Complaint Issued to Karam Asian Grocery and Halal Meat Corp. d/b/a Karam Asian Grocery…
  146. FDA-2011-P-0474-0004Acknowledgement Letter to DuVal & Associates, P. A. [Kalyto Medical, Inc.] - Correction
  147. FDA-2013-V-1450-0001Morriss Entertainment LLC - Application for Variance
  148. FDA-1987-V-0013-0002Variance Approval from FDA CDRH from Benedum Planetarium (Benedum Natural Science Theater)
  149. FDA-2021-S-0024-06842021-001022 - SmartyPants Vitamins - Teen Girl Formula - Supports normal immune function…
  150. FDA-2017-H-2222-0001CMP Complaint Issued to B and S Liquor Store, Inc. d/b/a B and S Liquor and Grocery
  151. FDA-2010-P-0091-0122Citizen Petition Denial Response from FDA CDER to Emily Robin
  152. FDA-2015-P-5108-0007Exhibit 6 NDA Review, NDA 20-553 E.D. Bashaw, PharmD, with Excerpts from Appendix to…
  153. FDA-2025-S-0024-01812025-000257 - Lallemand Health Solutions Inc. - Comforts Baby Probiotic Drops - Helps…
  154. FDA-2017-P-6029-0010Reference 7 FDA_Regulatory Considerations for Peptide Drug Products PPT re Citizen…
  155. FDA-2023-H-4767-0001Complaint
  156. FDA-2011-P-0646-0027Letter from Health Promotion Council to City of Philadelphia
  157. FDA-2018-S-0024-05232018001632- International Vitamin Corporation- Sunmark Calcium Citrate with Vitamin D3…
  158. FDA-2015-V-2766-0001Variance Application from DUNKLEY MUSIC
  159. FDA-2021-P-0894-0001Citizen Petition from Pet Schooled
  160. FDA-2012-S-1144-1753NBTY, Inc. - Phineas & Ferb Gummies - For Healthy Growth and Development
  161. FDA-2023-S-0024-01922023-000140 - Uqora Inc - Uqora Defend - Support your urinary tract health
  162. FDA-2003-V-0286-0001HFZ-300 to Insight Technology, Inc.
  163. FDA-2024-S-0024-12142024-002095 - VIVRI USA LLC- VIVRI Glp1 Double Booster- Double Hunger Blocker
  164. FDA-2013-D-1358-0002Draft Guidance for Industry: Recommendations for Premarket Notification (510(k))…
  165. FDA-2019-N-3065-0676Reference 81 - Design Features of Graphs in Health Risk Communication, 2006
  166. FDA-2019-H-3511-0001Complaint
  167. FDA-2001-S-0575-0027NDI 94 - Oral Porcine Relaxin - Original NDI Notifications
  168. FDA-2013-P-0862-0006Denial Response Letter from FDA CVM to Spec Pharma, LLC (Fish & Richardson P.C.)
  169. FDA-2025-H-6432-0001Complaint
  170. FDA-2009-N-0361-0001FDA/ORA to Hyman, Phelps & McNamara, P.C. (re Mary Holloway) - Letter
  171. FDA-2024-S-0024-09452024-001821 - Harris Tea Company (NJ)- MULTIPLE CLAIMS (4)
  172. FDA-2024-H-2319-0001Complaint
  173. FDA-2021-V-0828-0002Acknowledgment Letter from FDA DMS to Kirsten Shaheen
  174. FDA-2011-S-0932-1087Amerifit Brands (Amerifit, Inc. Estroven Mood & Memory Supplements)
  175. FDA-1992-P-0117-0002Attachment 1 Proposed Draft Labeling of Noromycin LA 300 re: Citizen Petition from Schafer…
  176. FDA-2025-V-5711-0002Acknowledgment Letter from FDA DMB to Kraig Knight
  177. FDA-2015-S-0023-0060NDI 871 - Bovine Serum Protein Concentrate - Original NDI Notification
  178. FDA-2025-A-1240-0002Acknowledgment Letter from FDA DMB to C. Humphrey & Associates, P.A.
  179. FDA-2018-D-2310-0004Process To Request a Review of the Food and Drug Administration’s Decision Not To Issue…
  180. FDA-2017-H-1648-0001CMP Complaint Issued to Silver Petroleum, Corp. d/b/a Mobil Mart
  181. FDA-2020-S-0024-0959SFC2020-001142 Louianna Inc - Oil of Oregano Capsules - Supports Immune System
  182. FDA-2017-S-0024-05302017000666 - International Vitamin Corporation - up&up Visionshield Eye Health Softgels…
  183. FDA-2023-V-1073-0001Variance Application from Gary Stadler
  184. FDA-2022-N-2390-0092Exhibit 203
  185. FDA-2001-N-0178-0025Reference 26 Geise, R. et al Radiation Doses during Pediatric Radiofrequency Catheter…
  186. FDA-2002-M-0199-0002Summary of Safety and Effectiveness Data (SSED)
  187. FDA-2005-P-0315-0006Amendment to Citizen Petition from Pfizer
  188. FDA-1975-N-0248-0129Answer from FDA/OC to Honorable Robert N. Giaimo Re: C104 Comment from Federal Paper Board…
  189. FDA-2023-V-4157-0002Acknowledgment Letter from FDA DMS to Jacks Urban Meeting Place
  190. FDA-2012-D-1002-0008Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Draft…
  191. FDA-2005-H-0506-0009Exhibit E - Office of General Counsel - Complaint's Motion for Protective Order Limiting…
  192. FDA-2011-S-0932-2889NBTY, Inc. - Bi-Mart Glucosamine & Chondroitin Supplements - Promotes Joint Health
  193. FDA-2018-D-0740-0001M7(R1): Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in…
  194. FDA-2018-R-1213-0001Complaint
  195. FDA-2024-V-1079-0002Acknowledgment Letter from FDA DMS to Propsav
  196. FDA-2011-S-0932-1781NBTY, Inc. - B-12 Supplements - Nervous Energy
  197. FDA-2016-H-0417-0001CTP CMP Case re Ysidro Pacheco Rodriguez d/b/a Junco 9
  198. FDA-2014-N-0002-0042Freedom of Information Summary ACTOGAIN (ractopamine HCl), RUMENSIN (monensin), TYLAN…
  199. FDA-2009-N-0163-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals
  200. FDA-2024-E-3579-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  201. FDA-2025-S-0024-07772025-000876 - LifeSeasons - LifeSeasons Therapeutics, Hormone Balance PCOS Formula - Work…
  202. FDA-2023-N-5160-0007Request for Extension from Animal Health Institute
  203. FDA-2024-H-5536-0001Complaint
  204. FDA-1982-N-0011-0184Background Material
  205. FDA-2023-N-4806-0001Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security…
  206. FDA-2019-H-1533-0001Complaint
  207. FDA-2010-N-0621-0194FDA/OC (CDER) to the Presiding Officer, Center for Biologics Evaluation and Research (Dr…
  208. FDA-2003-P-0364-0006FDA/OC to Abbott Laboratories et al - Petition Denial
  209. FDA-2020-D-1370-0026Final COVID-19: Developing Drugs and Biological Products for Treatment or Prevention…
  210. FDA-2023-N-3902-0267Comment from Anonymous
  211. FDA-1995-N-0054-13854Background Material for NFR 1
  212. FDA-2012-S-1144-0627Good Herbs, Inc. - Relieve Me - for relief from occasional constipation
  213. FDA-2019-H-2905-0001Complaint
  214. FDA-2023-P-4326-0002Attachment 1 Orange Book Listing re Suitability Petition from Reguliance LLC on behalf of…
  215. FDA-1997-S-0039-3030Perrigo - GoodSense and TopCare Glucosamine Chondroitin Complex - The Advanced Choice in…
  216. FDA-2017-H-5983-0001Complaint
  217. FDA-2008-P-0167-0003FDA/CDER to Lachman Consultant Services, Inc. - Petition Approval
  218. FDA-2014-S-0024-0688Perrigo Company (Perrigo - insync promotional) - Letter
  219. FDA-2019-H-5647-0001Complaint
  220. FDA-1996-N-0028-0012Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding for…
  221. FDA-2016-S-0024-1696Perrigo Co - Exchange Select™ - Calcium Magnesium & Zinc - Bone Health
  222. FDA-2016-S-0024-1956Perrigo - Promotional - CENTURY Adults 50+ Multivitamin supplies key nutrients in a…
  223. FDA-2001-D-0219-0007Supporting Statement
  224. FDA-1995-N-0054-13474Background Material for NFR 1
  225. FDA-1984-N-0259-0439Tapes of Transcripts 33 Tapes re: Letter Accompanying Purged Copies of Transcripts from…
  226. FDA-2023-V-2485-0002Acknowledgment Letter from FDA DMS to Bravas
  227. FDA-2003-P-0273-0030Appendix A - "Effects of Enoxaparin and Its Molecular Fractions on Endothelial Tissue…
  228. FDA-2015-S-0024-2623NBTY - Vitamin E with Selenium supplements - Supports heart health
  229. FDA-2011-S-0932-2245NBTY, Inc. - Vitamin B-12 - Metabolism Support
  230. FDA-1999-F-2405-1298Form Letter Sample#8 (Multiple Submitters=103) Form Letter Comment
  231. FDA-1997-S-0039-1436Herb Pharm - HERB PHARM - Promotes Healthy Appetite & Digestion
  232. FDA-2018-N-4465-0004Agency Information Collection Activities; Proposed Collection; Comment Request…
  233. FDA-2024-N-3001-0001Over-the-Counter Monograph Drug User Fee Program—OTC Monograph Order Request Fee Rates for…
  234. FDA-2015-N-0101-1492ACI Advice November 18 2020
  235. FDA-2019-N-1482-4313Mannion, Ray. Zynerba Pharmaceuticals
  236. FDA-2002-N-0264-0001Thomas Ronald Theodore; Debarment Order
  237. FDA-2012-D-0322-0052Ref 24. Closer to Zero_ Reducing Childhood Exposure to Contaminants from Foods _ FDA RE…
  238. FDA-2023-H-2637-0001Complaint
  239. FDA-2019-H-5945-0001Complaint
  240. FDA-2023-H-3515-0001Complaint
  241. FDA-2015-N-0001-0124Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
  242. FDA-2015-P-4600-0003Interim Response Letter from CDER to Bayer HealthCare LLC
  243. FDA-2023-S-0023-0005NDI 1268 -SAMe-DT with PG from JDS Therapeutics, LLC
  244. FDA-1979-N-0029-0012Discussion of Appropriate Testing Procedures for Exocrine Pancreatic Insufficiency Drug…
  245. FDA-2005-P-0316-0005Withdrawal Letter from Skadden, Arps, Slate, Meagher & Flom LLP on behalf of…
  246. FDA-2012-V-0942-0002Acknowledgement Letter to Rico Entertainment
  247. FDA-2004-N-0127-0003Supporting Statement - State Petitions for Exemption from Preemption
  248. FDA-2019-H-5952-0001Complaint
  249. FDA-2012-P-1259-0003Citizen Petition Approval Letter from FDA CDER to Hyman, Phelps, & McNamara, P.C.
  250. FDA-2012-V-0339-0002Acknowledgement Letter to DJ Doc Entertainment
  251. FDA-2025-H-3903-0001Complaint
  252. FDA-1981-D-0242-0001Notice of Availability from FDA
  253. FDA-2018-D-1635-0002Prescription Drug User Fee Act Waivers for Fixed Combination Antiretroviral Drugs for the…
  254. FDA-2014-S-0024-0538NBTY Inc (B 6) - Letter
  255. FDA-2020-S-0024-07622020-000918 NOW Foods - Lucky Vitamin, Psyllium Husk Caps - Helps Maintain Regularity
  256. FDA-2024-N-3480-0001Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025
  257. FDA-2022-V-1205-0001Variance Application from Camila De Avila
  258. FDA-2008-P-0187-0002Acknowledgement Letter to Olson & Cepuritis, Ltd.
  259. FDA-2015-F-0714-0010Indirect Food Additives: Paper and Paperboard Components
  260. FDA-2017-H-3767-0001CMP Complaint Issued to The Kroger Co. d/b/a Baker’s
  261. FDA-2023-N-4225-0002List of references 12 11 2024
  262. FDA-2020-S-0024-00802020-000098 International Vitamin Corporation- MULTIPLE CLAIMS (2)
  263. FDA-2011-P-0096-0004Acknowledgement Letter to Larken Laboratories, Inc. (Sovereign Pharmaceuticals, LLC)
  264. FDA-2023-H-0518-0001Complaint
  265. FDA-1991-P-0352-0001Citizen Petition from Public Citizen Health Research Group (HRG)
  266. FDA-2022-N-2390-0431Exhibit 110 - Lavedan (2015)
  267. FDA-2024-H-1256-0001Complaint
  268. FDA-2018-V-4596-0002Acknowledgment Letter from FDA DDM to Atomdesign LLC
  269. FDA-2023-P-0872-0003Exhibit 1 - Shinkowa Pharmaceutical RE Citizen Petition from Natural Products Association…
  270. FDA-2012-V-1132-0001Veeco MOCVD Operations - Application for Variance
  271. FDA-1997-S-0039-2206Indiana Botanic Cardens, Inc.- Probiotic Supreme Caplets- Facilitate the digestion of…
  272. FDA-2021-V-0826-0002Acknowledgment Letter from FDA DMS to Jared Fowler
  273. FDA-2024-H-4011-0001Complaint
  274. FDA-2024-E-0166-0005Determination of Regulatory Review Period for Purposes of Patent Extension; VANFLYTA
  275. FDA-2025-P-0753-0006Memorandum from FDA CDER
  276. FDA-2025-H-3385-0001Complaint
  277. FDA-2018-P-3102-0011Fleming-Harrington Redistribution Wash-in Washout (FHRWW): The Platinum Standard for…
  278. FDA-1977-N-0014-1073Answer Letter from FDA/Office of Legislative Services to Honorable Barber B. Conable, Jr…
  279. FDA-2011-D-0287-0001Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition…
  280. FDA-1984-G-0019-0048Letter from Wallerstein Company to FDA
  281. FDA-1997-S-0006-1068[LET1068] - FDA/ONLDS/CFSAN Response to Waiora, LLC - Courtesy Letter
  282. FDA-2012-S-1144-0331NBTY, Inc. - Glucosamine - Supports Joint Health
  283. FDA-1992-P-0122-0002Acknowledgement Letter from FDA Dockets Management Branch to Steris Laboratories Inc.
  284. FDA-2024-P-5469-0002Acknowledgment Letter from FDA DMB to Novitium Pharma, LLC
  285. FDA-1997-S-0039-2619Perrigo Company of South Carolina - Walgreens - Prenatal Complete - Vitamin D to support…
  286. FDA-2003-E-0328-0004Alcon Research, Ltd. - Patent Term Extension Application
  287. FDA-1992-N-0049-0006Reference 11 - "Iversen, Skin Tumorigenesis and Carcinogenesis Studies…
  288. FDA-2000-D-0135-0003Guidance for Industry - Effectiveness of Anthelmintics: Specific Recommendations for…
  289. FDA-2019-D-3805-0077The Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry…
  290. FDA-2018-D-2238-001615 Reference 14 - Design and Analysis of Shedding Studies for Virus or Bacteria -Based GT…
  291. FDA-2010-E-0662-0005Regulatory Review Period for Purposes of Patent Extension: JEVTANA
  292. FDA-2007-P-0010-0018Tab 3 - 72 FR 30386 - "Draft Guidances for Industry Describing Product-Specific…
  293. FDA-1967-P-0012-0001Accession 88-79-32 Box 18
  294. FDA-2023-H-3066-0001Complaint
  295. FDA-2010-S-0664-2324Perrigo - H-E-B Senior Complete - Cell Health and Repair
  296. FDA-2023-P-0203-0005Attachment 1 RE Citizen Petition from Najam Azmat
  297. FDA-2011-S-0932-0989New Chapter, Inc. (New Chapter St. John's Wort Force Supplements)
  298. FDA-2014-N-0189-4842Request for Extension from Anonymous
  299. FDA-2019-S-0024-07102019002537 - Swanson Health Products - Swanson Premium - Gummies Multivitamin - Supports…
  300. FDA-2008-P-0296-0014Enclosure 28 - Health canada endorsed important safety information regarding EVRA
  301. FDA-2014-N-0002-0014Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline…
  302. FDA-2017-P-4023-0036Attachment 34 Watson Pharmaceuticals Inc - Warning Letter re Citizen Petition from Sidley…
  303. FDA-2016-D-2335-1646Reference 29. Cifelli et al
  304. FDA-2017-H-4331-0001CMP Complaint Issued to G. Sharpco, Inc. d/b/a South Campbell Shell
  305. FDA-2019-D-0661-0001Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for…
  306. FDA-2014-N-2244-0274Reference 266 University_of_Missouri Extension_2008_National Setbacks Database re Draft…
  307. FDA-2011-S-0932-1542WN Pharmaceuticals, Inc. - Trunature CLA (conjugated linoleic acid) - Helps promote fat…
  308. FDA-2023-H-4678-0001Complaint
  309. FDA-2024-H-0372-0001Complaint
  310. FDA-2020-S-0023-0026NDI 1140 - ZBGTECH Compound Liquid Supplement - Reference List
  311. FDA-1997-S-0039-1069Letter from Perrigo Company of South Carolina
  312. FDA-2014-P-0861-0001Citizen Petition From Clinipace Worldwide
  313. FDA-1982-G-0253-0067FDA Memorandum to Docket 1982G-0178
  314. FDA-2019-H-5859-0001Complaint
  315. FDA-1994-P-0041-0240See FDA-1994-P-0041-0252
  316. FDA-2023-D-2509-0001Volume Limits for Automated Collection of Source Plasma
  317. FDA-2007-D-0369-0870PSG_215383 - Draft Guidance on Belzutifan)
  318. FDA-2005-N-0096-0001Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug…
  319. FDA-2013-H-1236-0001Complaint
  320. FDA-2015-V-2143-0003Variance Supplement to 15A0192 (FDA-2015-V-2143)
  321. FDA-2019-P-2038-0001Citizen Petition from American Dental Association
  322. FDA-2024-H-2260-0001Complaint
  323. FDA-2015-P-3107-0001Citizen Petition from Ferrosan Medical Devices (DuVal & Associates)
  324. FDA-2016-N-1284-0001Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug…
  325. FDA-2014-H-1852-0001Complaint
  326. FDA-2025-P-3072-0003Exhibit A - Email Correspondence from FDA CTP
  327. FDA-2018-H-3162-0001Complaint
  328. FDA-2008-E-0204-0005FDA Center for Drug Evaluation Research to the USPTO - Letter
  329. FDA-2004-N-0451-0029Food and Drug Administration Modernization Act of 1997: Modifications to the List of…
  330. FDA-2006-D-0298-0020Exhibit 3 - "Review of the Whole Grain Council's 2009"Whole Grain Research Summary"…
  331. FDA-2014-P-0814-0016Exhibit 18 Lerman, R. FDA halts trial of cancer drug by Seattle's CTI BioPharma after…
  332. FDA-2023-N-1585-000504-Reference_Updates on possible mitigation strategies to reduce the risk of nitrosamine…
  333. FDA-2020-D-0957-0151151-Premarket-Approval-Application-Modular-Review
  334. FDA-2016-H-0704-0002Complaint
  335. FDA-2025-H-4582-0001Complaint
  336. FDA-2009-N-0215-0003Agency Information Collection Activities; Proposals, Submissions, and Approvals…
  337. FDA-2018-S-0024-05422018001651-Blis Technologies Ltd - MULTIPLE CLAIMS (4)
  338. FDA-2020-S-0024-08032020-000964 FoodState - MegaFood, Relax + Calm Magnesium Powder - Supports a sense of calm…
  339. FDA-2021-V-0454-0003Variance Approval Letter from Grand Home Automation
  340. FDA-2003-P-0005-0006Attachment 4 - Letter from Lonnie W. Luther, Chief, Metabolic Products Branch to A.L…
  341. FDA-2017-H-1404-0001CMP Complaint Issued to Nan Robert DBA Cafetin Pellin Inc. d/b/a Cafetin Pellin
  342. FDA-2023-N-3902-0257Comment from Elizabeth Songalia
  343. FDA-2025-P-4154-0001Citizen Petition from Hyman, Phelps & McNamara, P.C.
  344. FDA-2025-H-3222-0001Complaint
  345. FDA-2011-E-0117-0009Letter to U. S. Patent and Trademark Office
  346. FDA-1976-N-0476-0036Schedule of Hearing, February 15-16, 1977 re: Good Laboratory Practices for Nonclinical…
  347. FDA-1990-P-0030-0005Petition Approval from FDA to Pfizer Inc.
  348. FDA-1996-N-0028-0442Reference 18 - "FDA Health Hazard Evaluation, Classification, and FDA Enforcement Report…
  349. FDA-2011-S-0932-1796NBTY, Inc. - Vitamin D3 Supplements - Bone, Colon and Breast Health
  350. FDA-2020-N-1082-0003Reference 6 - Moorman et al Heptaology 2015 re Microbiology Devices; Reclassification of…
  351. FDA-2017-H-1564-0001CMP Complaint Issued to Hahn Northside Inc. d/b/a Sunoco
  352. FDA-1990-G-0246-0162Acknowledgment Letter to Center for Regulatory Services, September 2, 1988
  353. FDA-2019-V-0439-0001Variance Application from John Odom
  354. FDA-2013-N-0403-0010Agency Information Collection Activities; Proposed Collection; Comment Request; Protection…
  355. FDA-2025-V-4546-0002Acknowledgment Letter from FDA DMB to Daniel Fry
  356. FDA-2014-N-1021-0558Attachment A-17 Tanner GJ, et al Measuring Hordein (Gluten) in Beer - A Comparison of…
  357. FDA-2023-H-2643-0001Complaint
  358. FDA-2016-E-2477-0008Notice of Final Determination
  359. FDA-2008-E-0092-0002USPTO - Letter
  360. FDA-2019-N-3926-0005Request for Nominations for Voting Members on Public Advisory Panels of the Medical…
  361. FDA-2014-N-0189-58094Request for Extension from Anonymous
  362. FDA-2023-V-0031-0001Variance Application from PL Productions
  363. FDA-2024-N-5471-0751PRIA Reference 82 Bahl Thirdhand Cigarette Smoke Factors Affecting Exposure and…
  364. FDA-2017-F-3717-0003Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
  365. FDA-2021-S-0024-13982021-3313 Mindworks Innovations dba BrainMD - MULTIPLE CLAIMS (2)
  366. FDA-2010-S-0664-0767Vitacost.com, Inc. d/b/a Nutraceutical Sciences Institute - NSI Acetyl L-Carnitine HCI…
  367. FDA-2012-S-1178-0061Novel Foods Unit Runderlactoferrine Bovine re NDI 751, Lactoferrin Bioferrin 6000 from…
  368. FDA-2023-V-0783-0002Acknowledgment Letter from FDA DMS to Grateful Shed
  369. FDA-1991-N-0006-0079FDA
  370. FDA-2024-H-0459-0001Complaint
  371. FDA-2001-S-0575-0037NDI 97 - L-Se-methylselenocysteine (SeMC) - Original NDI Notification
  372. FDA-2003-V-0296-0001See FDA-2003-V-0296-0002
  373. FDA-2008-D-0597-0010See FDA-2008-D-0597-0009
  374. FDA-2018-H-4260-0001Complaint
  375. FDA-1997-S-0039-0927Perficio Networks, Inc. DBA: YOR - YOR CompleteBum - Weight Loss Solution
  376. FDA-2018-V-0232-0002Acknowledgement Letter from FDA DDM to Laser Fusion Inc.
  377. FDA-2014-N-0189-4828Request for Extension from Anonymous
  378. FDA-2007-D-0369-2192PSG_217581 - Draft Guidance on Crizotinib
  379. FDA-2007-D-0369-2271PSG_217186 - Draft Guidance on Carbidopa; Levodopa
  380. FDA-2006-P-0276-0006Attachment 1 Copies of Pictures of Odin Before the Blockage and Illnesses Resulting from…
  381. FDA-1997-S-0006-0855HFS-810 to Biotech Corporation - Letter - Let 544
  382. FDA-2013-N-1064-0006Agency Information Collection Activities; Announcement of Office of Management and Budget…
  383. FDA-1989-G-0171-0037Supplement from Keller & Heckman re Lysozyme GRAS Petition
  384. FDA-2014-N-0189-7376Request for Extension from Anonymous
  385. FDA-2007-D-0070-0002Certain HCT/Ps Recovered from Donors Who Were Tested for Communicable Diseases Using…
  386. FDA-1978-N-0014-0001Antacid Drug Products For Over-The-Counter Human Use Final Classification of Category III…
  387. FDA-1976-N-0027-0201Supplement from Consumer Healthcare Products Association - Appendix 2: Part 2
  388. FDA-2014-H-1085-0001Complaint
  389. FDA-2010-N-0062-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  390. FDA-2023-P-4443-0007Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.
  391. FDA-2022-H-2119-0001Complaint
  392. FDA-2013-N-0227-0168Reference 100 Davies Examination of Incoming Materials Inspection Instructions 1974
  393. FDA-2016-N-3118-0075redacted_056_Pharmaco Memo Attachment
  394. FDA-2024-V-1589-0001Variance Application from Dot, LLC
  395. FDA-2002-N-0265-0051Eminent Research Systems, Inc. - Electronic Request for Appearance
  396. FDA-1997-S-0006-0233FDA/CFSAN to Alltech Biotechnology Center
  397. FDA-2019-P-2289-0010References for Depression Mood Disorders and Suicide re Citizen Petition from…
  398. FDA-2016-Q-3770-0131Reference 129 - ROLE OF MAGNESIUM IN THE MANAGEMENT OF HYPERTENSION re Qualified Health…
  399. FDA-1979-F-0034-0001Filing of Petition for Food Additive Permitted in Feed and Drinking Water of Animals…
  400. FDA-2024-E-5010-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  401. FDA-1984-P-0008-0002HFC-2 to National Soft Drink Association
  402. FDA-2006-E-0061-0005USPTO to FDA/CDER - Letter
  403. FDA-2019-P-2945-0001Citizen Petition from Jesse J LeBlanc III
  404. FDA-2003-N-0044-0003Supporting Statement - Impact of Risk Management Programs on the Practice of Pharmacy
  405. FDA-1998-P-0083-0002Reference List Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug…
  406. FDA-2015-H-5059-0001CTP CMP Case re Arthur Kharatyan d/b/a La Brea Newsstand / La Brea Cigarettes
  407. FDA-2002-N-0320-0001FDA
  408. FDA-2016-D-3466-0002Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing…
  409. FDA-2016-M-3915-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  410. FDA-2007-D-0367-0017Vision Council of America (VCA) - Request for Extension Comment Due Date
  411. FDA-1992-V-0341-0005Variance Approval Response Letter from FDA CDRH to Oregon Museum of Science and Industry…
  412. FDA-1991-N-0006-0002FDA
  413. FDA-2022-E-0661-0003Letter to U S Patent and Trademark Office from FDA CDER
  414. FDA-2022-D-0467-0137134 HIV - Factors assoc high trans risk HIV-infected MSM on ART
  415. FDA-2011-A-0363-0003Exhibit 1 - "Request for Advisory Opinion by GSK dated January 10, 2005, Docket No…
  416. FDA-2018-D-0943-0008Elemental Impurities in Animal Drug Products—Questions and Answers; Draft Guidance for…
  417. FDA-2012-N-0145-0004Agency Information Collection Activities; Submissions for Office of Management and Budget…
  418. FDA-2011-S-0932-0184Letter from NBTY, Inc.
  419. FDA-2013-N-0485-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic…
  420. FDA-2024-E-4125-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  421. FDA-2014-S-0024-0369Perrigo Company (Sunmark and Health Mart - D3) - Letter
  422. FDA-2002-D-0145-0002FDA
  423. FDA-1992-N-0049-0014Reference 7 - "Comments C31, PR1, & PR2" - [Topical Drug Products Containing Benzoyl…
  424. FDA-2022-V-0797-0002Acknowledgment Letter from FDA DMS to Sahoma Lanes
  425. FDA-2020-E-2120-0002Patent Term Extension Application for TABRECTA® Patent No 7,767,675
  426. FDA-2022-V-1220-0002Variance Application from George Gayl
  427. FDA-1993-G-0218-0117Part R-23: Section I - Chemical Identity for Oat Fiber and for Hydrogen Peroxide…
  428. FDA-2024-N-0730-0001Cheese Slice Products Deviating From Identity Standard; Temporary Permit for Market…
  429. FDA-2024-H-0460-0001Complaint
  430. FDA-2012-V-0960-0002Acknowledgement Letter to Pary King Entertainment
  431. FDA-2015-N-0101-1351Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products…
  432. FDA-2009-S-0607-0250Perrigo - Good Neighbor Pharmacy One Daily - Healthy Skin
  433. FDA-2017-N-1748-0001Guerbet Group; Withdrawal of Approval of Two New Drug Applications
  434. FDA-2025-P-5493-0003Abrao article for PGIC FDA Citizen Petition-Orilissa
  435. FDA-2025-V-6892-0002Acknowledgment Letter from FDA DMB to Totally Wired
  436. FDA-2003-P-0351-0007Acknowledgement Letter to Lachman Consultant Services, Inc.
  437. FDA-2024-V-4233-0001Variance Application from Stage Productions
  438. FDA-2024-H-0093-0001Complaint
  439. FDA-2017-H-2311-0001CMP Complaint Issued to Skipper Beverage Company, LLC d/b/a Valero Corner Store 2316
  440. FDA-1984-P-0344-0016Letter from FDA to Ralston Purina Co.
  441. FDA-2008-P-0554-0001MyaThomae Consulting, Inc. - Citizen Petition
  442. FDA-2011-P-0081-0009Armenpharm, Ltd. - Supplement
  443. FDA-2013-S-0024-0474Highland Laboratories - Folic Acid and B12 original formula - Supports healthy RNA and DNA
  444. FDA-2016-V-3053-0001Variance Application from Mayan Warrior Productions Inc.
  445. FDA-2016-D-1814-0037Preparation of Food Contact Notifications for Food Contact Substances in Contact With…
  446. FDA-1995-N-0063-0110Reference 7 Congressional Record House Vol 126 Dated May 20, 1980
  447. FDA-1977-N-0002-1208Answer Letter from FDA/Office of Legislative Services to Honorable Bill Proxmire, United…
  448. FDA-1997-S-0006-0402HFS-456 to Woodland Farm Ltd - Letter - Let 111
  449. FDA-2016-N-0124-0153Reference 109 - BKC RED EPA 06 re Safety and Effectiveness of Consumer Antiseptics…
  450. FDA-2016-P-1088-0004Attachment 2 Package Information Oxybutynin Hydrochloride 2.5 mg and 5 mg Tablets re…
  451. FDA-1993-G-0220-0026Section 8.D.1 - List of Literature References
  452. FDA-2017-H-5158-0001Complaint
  453. FDA-1976-N-0519-0041Letter from FDA/CDER to Public Citizen Health Research Group
  454. FDA-2015-S-0024-1380Lang Pharma Nutrition Inc - CVS Satin Collection Calcium 500 mg + D3 - Bone Health
  455. FDA-2016-C-2767-0005Safety Review of CAP 6C0307 Calcium Carbonate as a Color Additive_redacted
  456. FDA-2007-P-0346-0002Richard Sauerheber, Palomar College - Supplement Citizen Petition (1)
  457. FDA-2011-S-0932-2771NBTY, Inc. - Prostene Supplements - Prostate Support Formula
  458. FDA-2014-N-0189-6291Request for Extension from Anonymous
  459. FDA-2024-N-5471-0766PRIA Reference 97 Taylor Change in mental health after smoking cessation 2014
  460. FDA-2012-P-0462-0002Acknowledgement Letter to Douglass Oeller Consulting, Inc.
  461. FDA-2016-S-0024-0713NBTY - Vitamin C with Rose Hips supplements under the Healthy Accents label - Supports…
  462. FDA-2024-H-5079-0001Complaint
  463. FDA-2016-H-0859-0001CTP CMP Case re Pedro Reyes d/b/a Ulloa Mini Market
  464. FDA-2009-R-0358-0002Proposal to Disqualify Jeffrey N. Davidson, D.V.M. - Commissioner's Decision
  465. FDA-2006-P-0141-0002Acknowledgement Letter from FDA DMB to John D. Stephens, M.D.
  466. FDA-2025-S-0024-00412025-000085 - Piping Rock Health Products - Renew Life Men's Care Ultimate Flora ™…
  467. FDA-2008-N-0513-0013Wolf Maier, Delegation of the European Union Commission - Testimony
  468. FDA-1976-N-0519-0124Tab 5 - VapoRub Nasal Decongestant - Table 5 re Comment from Richardson-Vicks U.S.A.
  469. FDA-2016-S-0024-0069Emord & Associates behalf Four, LLC - Crave Crush - Dissolving one lozenge on your tongue…
  470. FDA-2014-E-2355-0005Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA
  471. FDA-2005-P-0054-0003FDA/CDER to Cinergen
  472. FDA-2023-N-3902-0025List of References re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used…
  473. FDA-2022-D-1494-0018CVM Guidance For Industry 97 VICH GL14 Effectiveness of Anthelmintics: Specific…
  474. FDA-2015-N-2819-0003Emergency Permit Control Regulations; Technical Amendments
  475. FDA-2009-N-0664-0098Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory…
  476. FDA-2021-S-0024-03862021-000627 Swanson Health Products- Zinc Picolinate- Supports immune health and daily…
  477. FDA-1990-S-0006-0061Statistical Report - Month of January 2004
  478. FDA-2023-P-4876-0009Final Response Letter from FDA CDER to Strides Pharma Inc.
  479. FDA-2016-P-3418-0012Attachment 9 Abbreviated New Drug Application Regulations, 57 Fed. Reg. at 17,950 (Apr…
  480. FDA-1999-P-0026-0001FDA/CDER to Public Citizen Health Research Group - Petition Partial Approval and Denial
  481. FDA-2020-V-2295-0001Variance Application from Rune Hansen
  482. FDA-2014-N-0189-35196Request for Extension from Kathy Jordan
  483. FDA-1996-N-0028-0080Pre_FDMS - OMB Review 10/25/2005
  484. FDA-2021-D-0593-0001Collecting and Providing 702(b) Portions of Food and Drug Administration Official…
  485. FDA-2021-S-0024-07982021-000793 - EuroPharmaTerry NaturallyEuroMedica - Terry Naturally, Bronchial Clear…
  486. FDA-2012-P-0040-0001Fischer Surgical, Inc. - Citizen Petition
  487. FDA-1997-S-0039-1273Letter from Perrigo Company of South Carolina
  488. FDA-2017-H-3637-0001CMP Complaint Issued to Kroger Limited Partnership I d/b/a Kroger Fuel Center J993
  489. FDA-2018-D-3583-0018Reference 6_Fatica_2017_Memorandum of Record Fresh-cut Produce Related Outbreak Data…
  490. FDA-2005-N-0095-0002Transcript of the December 15, 2005 Joint Meeting with FDA and FSIS
  491. FDA-1990-G-0246-0257Enclosure 10 - Addendum I - Protocol for a Life-Span Oral Carcinogenicity Study in Mice re…
  492. FDA-2000-V-0004-0001FDA/CDRH to Mighty Ducks Hockey Team - Approval for Variance
  493. FDA-2023-P-4288-0001Suitability Petition from Pharmobedient Consulting, LLC.
  494. FDA-2005-P-0255-0001number not used
  495. FDA-1997-G-0376-0025Reference 33 - Description of Erythritol - Appendix 1/13 - Technical Paper: Quantitative…
  496. FDA-2025-H-1937-0001Complaint
  497. FDA-2006-P-0033-0037Exhibit C - "Maki, et al., A Plant Sterol/Stanol Supplement in Tablet Form Lowers LDL and…
  498. FDA-2019-H-0230-0001Complaint
  499. FDA-2024-H-0340-0001Complaint
  500. FDA-2003-V-0191-0001See FDA-2003-V-0191-0003
  501. FDA-1982-P-0018-0233Background Material
  502. FDA-2013-P-1374-0033Supplement from Frederick Mayer, PPSI
  503. FDA-2024-D-2977-0497Food and Drug Administration Enforcement Policy for Association of American Feed Control…
  504. FDA-2022-S-0024-05572022-000576 - Schwabe North America, Inc. - Multiple Claims (2)
  505. FDA-2018-D-2032-0022Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
  506. FDA-2024-H-5216-0001Complaint
  507. FDA-2022-D-1503-0005Q14 ANALYTICAL PROCEDURE DEVELOPMENT DRAFT GUIDANCE
  508. FDA-1997-S-0006-2201Courtesy letter and related material from HFP to Mannatech
  509. FDA-2014-N-0189-5703Request for Extension from Anonymous
  510. FDA-2005-P-0057-0004Withdrawal Memo from FDA Office of Regulatory Policy re Citizen Petition from Hyman…
  511. FDA-2009-S-0607-0142Dee Cee Laboratories - #741 TMG - Promotes Healthy Homocysteine Levels
  512. FDA-2022-V-1243-0002Acknowledgment Letter from FDA DMS to Ive Nelson
  513. FDA-2021-E-0379-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  514. FDA-2017-P-6745-0002Acknowledgement Letter from FDA DDM to Foley Hoag LLP
  515. FDA-1977-N-0002-1411Answer Letter from FDA to Comment from The Honorable Robert W. Kasten, Jr., United States…
  516. FDA-2014-N-0189-4682Request for Extension from Anonymous
  517. FDA-2022-S-0024-02892022-000281 - Chattem Inc. - Unisom Simple Slumbers, Sleep + Immunity - Helps you fall…
  518. FDA-2007-D-0369-1035PSG_215974 - Draft Guidance on Lenacapavir Sodium
  519. FDA-2003-D-0089-0046Background Material
  520. FDA-1996-N-0028-0011Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding for…
  521. FDA-2011-E-0269-0006U.S. Patent and Trademark Office, Notice of Final Determination - Letter
  522. FDA-2023-H-1048-0001Complaint
  523. FDA-2024-V-5882-0002Acknowledgment Letter from FDA DMB to Lunaglow
  524. FDA-2019-H-5098-0001Complaint
  525. FDA-2025-P-6089-0014Reference 12 - PEGylation - Wikipedia
  526. FDA-2008-P-0196-0002Acknowledgement Letter to Carmel Pharma, Inc.
  527. FDA-1995-N-0384-0001Carcinogenicity Testing of Compounds Used in Food-Producing Animals
  528. FDA-2025-P-2525-0007Completeness Assessment Correspondence
  529. FDA-2016-V-3412-0001Variance Request from Toshiba America Medical Systems, Inc.
  530. FDA-2025-E-0495-0005Letter to U. S. Patent and Trademark Office
  531. FDA-2004-P-0215-0027Point 4 Reference - [Hill Dermaceuticals Inc. - Supplement] re FDA-2004-P-0215-0010
  532. FDA-2016-H-2266-0001Complaint
  533. FDA-2006-N-0183-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
  534. FDA-2013-D-0710-0019Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or…
  535. FDA-2008-P-0327-0001Kendle Regulatory Affairs - Citizen Petition
  536. FDA-2001-V-0221-0001HFZ-300 to Ace Mitchell Bowler's Mart
  537. FDA-1982-P-0018-0317Background Material
  538. FDA-2017-H-1380-0001CMP Complaint Issued to Casey’s General Stores, Inc. d/b/a Casey’s General Store 2972
  539. FDA-2010-S-0664-0628North American Pharmacal, Inc. - Polyflora O - Probiotic Formula Designed for Type O…
  540. FDA-1999-N-0134-0087Risk Assessment
  541. FDA-2022-N-2390-0302Exhibit 166
  542. FDA-2014-D-1814-0118Supplemental Comment from New York Blood Center (NYBC)
  543. FDA-2018-N-4731-0001Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop…
  544. FDA-2021-P-0340-0002Acknowledgment Letter from FDA DMS to Drug Device Consulting LLC
  545. FDA-1982-N-0264-0004FDA/CDER Response to Buchanan Ingersoll & Rooney PC, March 2, 2011 - Letter
  546. FDA-2012-F-1100-0001DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
  547. FDA-2023-H-0432-0001Complaint
  548. FDA-2013-N-0227-0206Reference 137 Philip Morris Process Validation OBT Quality System Meeting 2001
  549. FDA-2016-D-2841-0002Draft Guidance for Draft Guidance for Describing a Hazard That Needs Control in Documents…
  550. FDA-2020-V-1784-0002Variance Application from Devin Peterson
  551. FDA-2015-S-0024-0200Perrigo Company - H-E-B®- Adults 50 + Complete - B vitamins help support energy production
  552. FDA-2016-N-0321-0001Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in…
  553. FDA-2009-V-0516-0002Acknowledgement Letter to Venue Supply Company
  554. FDA-2013-H-1235-0001Complaint
  555. FDA-2025-H-0303-0001Complaint
  556. FDA-2013-N-1524-1799Nomination Letter Clioquinol re: Comment from Fagron
  557. FDA-2023-H-3744-0001Complaint
  558. FDA-2013-V-1007-0003FDA/CDRH Response to ER Productions - Approval of Variance
  559. FDA-2020-P-2010-0008Citizen Petition Response from FDA CDRH to Philips Respironics
  560. FDA-2021-P-1334-0007Tab 5 - MOU 225-86-8251 re: Citizen Petition from Hogan Lovells US LLP on behalf of…
  561. FDA-2024-S-0024-13192024-002210 - Iovate Health Sciences International Inc.- Six Star Creatine X3- support…
  562. FDA-2024-S-0024-03622024-001106 - Comfort Click Limited - WeightWorld Vitamin D3 5000IU +K2 120mcg-120…
  563. FDA-2025-H-1420-0001Complaint
  564. FDA-2016-N-3389-0042Reference 02-38 The effect of apple fibre on diabetic control and plasma lipids re…
  565. FDA-2004-D-0123-0002See FDA-2004-D-0123-0003
  566. FDA-2004-P-0481-0005Attachment 1
  567. FDA-2021-S-0024-08052021-000808 - Jarrow Formulas Inc. - Jarrow Formulas NMN - Supports Energy Production
  568. FDA-2025-H-1632-0001Complaint
  569. FDA-2008-D-0180-0002Coronary Drug Eluting Stents- Nonclincal and Clinical Companion Document - Draft Guidance
  570. FDA-2021-N-0471-0418Tab B-Final Rule-Comparison OMB Original to Final Version
  571. FDA-2022-S-0024-12052022-125 - Interplexus - MULTIPLE CLAIMS (2)
  572. FDA-2016-H-0428-0002Complaint
  573. FDA-2024-V-4288-0001Variance Request from U.M.B. C. Center for Art, Design and Visual Culture
  574. FDA-2023-P-2655-0002Acknowledgment Letter from FDA CDER to Epic Pharma LLC
  575. FDA-2018-D-1216-0018Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study…
  576. FDA-2022-H-3358-0001Complaint
  577. FDA-2021-N-1243-0001Prospective Grant of an Exclusive Patent License: A Diagnostic Tool Based Upon Magnetic…
  578. FDA-2014-N-0189-6961Request for Extension from Anonymous
  579. FDA-2023-H-2930-0001Complaint
  580. FDA-2009-M-0101-0023Bard Access Systems, Inc. - Information
  581. FDA-2024-S-0024-13092024-002200 - Highland Laboratories Inc- Mt. Angel Vitamins, Triple B-12- Supports Nervous…
  582. FDA-1997-G-0376-0010Reference 4 Description of Erythricol Appendix 1 /3 Validation Study of HPLC Analysis for…
  583. FDA-2010-S-0664-0598Healthy Solutions, LLC. - AlphaSorb-C 500 - Antioxidant Protection
  584. FDA-2017-H-4459-0001CMP Complaint Issued to Sandy Ridge Corp. d/b/a Liquor Land
  585. FDA-2014-S-0023-0062NDI 837- 1,6-bis [L-phenylalanin-N-alpha-amino] hexanediamide from Smith-Ennismore…
  586. FDA-2018-V-4701-0001Variance Application from Brite House LLC
  587. FDA-2018-S-0024-08922018001931- FoodState (Product ManufacturingWarehouse- MegaFood Kids N Us MegaFlora…
  588. FDA-2024-P-4134-0011Reconsideration Response Letter
  589. FDA-1975-N-0010-0014Antibiotic, Nitrofuran, and Sulfonamide Drugs In the Feed of Animals Notice of Proposed…
  590. FDA-2024-N-5471-0001Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted…
  591. FDA-2023-H-2327-0001Complaint
  592. FDA-2014-N-0189-5472Request for Extension from Kyle
  593. FDA-2018-H-4637-0001Complaint
  594. FDA-1985-P-0076-0003Interim Response from FDA CFSAN to Continental Can Company, Inc.
  595. FDA-2022-H-1431-0001Complaint
  596. FDA-1979-F-0033-0003Finding of No Significant Impact by FDA
  597. FDA-2020-D-1976-0001CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device…
  598. FDA-2023-S-0024-07522023-001699 - Nordic Naturals- Nordic Naturals Vitamin C Extra Strength Gummies- Supports…
  599. FDA-2007-P-0250-0003FDA Response to Kendle International - Letter
  600. FDA-2021-N-0553-1982FG-Ref 18-Citizen Petition-Rye-Barley-Allergens-Celiac Disease
  601. FDA-2017-S-0024-0129Fernandez Y Canivell on behalf of Ms Bros America Corp, CE REGUMIL ECHINACEA PROPOLIS…
  602. FDA-2020-N-2246-0001Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
  603. FDA-2006-E-0380-0010U.S. Patent & Trademark Office to Merck & Co., Inc. - Certificate Extending Patent Term
  604. FDA-2018-N-3163-0021Agency Information Collection Activities; Announcement of Office of Management and Budget…
  605. FDA-2017-H-6033-0001Complaint
  606. FDA-2014-S-0024-0349CytoSports Inc (Cytomax Powder Supplement) - Letter
  607. FDA-2022-S-0024-07652022-000829 - HERBALIFE INTERNATIONAL OF AMERICA, INC. - Fat Release - Fruit Twist - For…
  608. FDA-2011-S-0932-0207Letter from NBTY, Inc.
  609. FDA-2013-S-0610-0003Electronic Method for Specific Electronic Submissions to FDA's Dockets Management Staff
  610. FDA-2012-N-0001-0108Nonprescription Drugs Advisory Committee Meeting
  611. FDA-2012-N-0427-0004Agency Information Collection Activities; Proposed Collection; Comment Request; Medical…
  612. FDA-2016-F-1805-0003Indirect Food Additives: Polymers
  613. FDA-1992-N-0056-0007Notice of Final Rule re Prescription Drug Marketing Act of 1987; Prescription Drug…
  614. FDA-2020-P-2033-0005Interim Response Letter from FDA DMS to Kentucky Drug Quality Study
  615. FDA-2018-S-0024-03012018001471 - Jarrow Formulas, Inc. - Jarrow Formulas® Borage - Promotes Healthy Skin and…
  616. FDA-2002-P-0215-0001FDA/DDM to Shotwell & Carr, Inc.
  617. FDA-2011-V-0864-0002Acknowledgement Letter to Pro-Mix Audio and Lighting
  618. FDA-2012-S-1144-2147NBTY, Inc. - Vitamin E - Supports Heart Health
  619. FDA-2021-P-0267-0010Reference 8, 9, 10 - Brain damage in infant mice following oral intake of glutamate…
  620. FDA-2004-P-0217-0001Acknowledgment Letter from FDA DMB to Ben Venue Laboratories, Inc.
  621. FDA-2023-E-1550-0007Letter to U.S. Patent and Trademark Office
  622. FDA-2025-H-3347-0001Complaint
  623. FDA-2022-H-0325-0001Complaint
  624. FDA-2015-H-4406-0001CTP CMP Case re Family Dollar Stores of Pennsylvania, Inc. d/b/a Family Dollar 5932
  625. FDA-2021-V-0749-0001Variance Application from City Of Baytown Police Department
  626. FDA-2024-H-2806-0001Complaint
  627. FDA-1977-N-0002-0959Answer Letter from FDA to Comment from the Honorable John Sparkman, United States Senate
  628. FDA-2017-E-3485-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  629. FDA-2019-H-1037-0001Complaint
  630. FDA-2020-E-1281-0035Tab 16 - Net2Globe v Time Warner (2003)
  631. FDA-2013-P-1287-0004Citizen Petition Dennial Response from FDA CDER to Apatalis Pharma US, Inc.
  632. FDA-2016-H-1709-0001Complaint
  633. FDA-2016-P-4275-0051Appendix C - U S FDA 2016d re Citizen Petition from BioNeutra North America Inc
  634. FDA-2023-H-2782-0001Complaint
  635. FDA-2008-N-0326-0007Reference 6 - CDC Enteric Disease Branch, Animal-to-man Transmission of…
  636. FDA-2016-S-0024-1477Perrigo - Shopko®-CENTURY - Energy Production
  637. FDA-2012-P-1029-0001Citizen Petition from Lachman Consultant Services Inc.
  638. FDA-2009-N-0184-0034FDA to Chad A. Landmon, Axinn Veltrop & Harkrider LLP - Letter
  639. FDA-2023-V-4514-0001Variance Application from Jordan Stone
  640. FDA-2010-N-0101-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Human…
  641. FDA-2013-H-0153-0001Complaint
  642. FDA-2025-H-5553-0001Complaint
  643. FDA-2020-H-0572-0001Complaint
  644. FDA-2008-N-0039-0069Freedom of Information Summary Chloramine - T Soluble Powder for Immersion Freshwater…
  645. FDA-2025-H-0144-0001Complaint
  646. FDA-2013-D-1181-0001Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing…
  647. FDA-2006-D-0032-0002Draft Guidance
  648. FDA-2018-H-4043-0001Complaint
  649. FDA-2020-N-2029-0279Appendix 5 - Addendum to CDER Decisional Memorandum NDA 021945 Makena RE Briefing…
  650. FDA-2017-P-2233-0010Attachment 8 - Dentsply, Annual Report per SEC Form 10-K (31 Dec_ 2014) re Citizen…
  651. FDA-2018-N-3091-0001Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
  652. FDA-2012-S-1144-1266Pure Essence Labs - CalmEssence - Provides 150 mg of Suntheaninee (the amount in 30-75…
  653. FDA-2020-H-0103-0001Complaint
  654. FDA-1997-S-0006-1464Courtesy letter from CFSAN to BEND BEAUTY INC
  655. FDA-2011-S-0932-1348NBTY, Inc. - B-12 - Contributes to normal brain function
  656. FDA-2024-H-3019-0001Complaint
  657. FDA-2011-N-0002-0019Meetings: Antiviral Drugs Advisory Committee
  658. FDA-1996-N-0028-0483Reference 88 - "Case: State of Louisiana v. Matthews, 427 F.Supp. 174 (E.D. La. 1977)"…
  659. FDA-1999-N-0113-0127Background Information
  660. FDA-2016-S-0024-1431Waterpure, Inc - Krill Omega 50+® CoQ10 - Supports Cardiovascular Health
  661. FDA-2018-H-1138-0001Complaint
  662. FDA-1980-N-0038-0517Reply to Motion from FDA CDER
  663. FDA-1997-S-0039-2338Perrigo - Multiple claims - 2
  664. FDA-2007-D-0369-1063PSG_021057 - Draft Guidance on Ganirelix Acetate
  665. FDA-2015-H-5034-0001CTP CMP Case re Food Lion, LLC d/b/a Food Lion 297
  666. FDA-2016-D-4317-0007Final Guidance for Industry Compounding and Repackaging of Radiopharmaceuticals by…
  667. FDA-2025-H-1207-0001Complaint
  668. FDA-2024-H-3429-0001Complaint
  669. FDA-2020-E-2337-0008Letter from U.S. Patent and Trademark Office to CDER
  670. FDA-2016-P-3674-0023Interim Response Letter from CDRH to Consumers for Dental Choice
  671. FDA-1981-N-0114-0027Reference 18 - "Comment No. C1, Target Health Inc., 1992N-0311" - [Classification of…
  672. FDA-2015-H-4333-0001CTP CMP Case re Parth Lane, Inc. d/b/a Minit Mart Discount Beverage
  673. FDA-2011-N-0179-0027Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry…
  674. FDA-2019-N-0007-0003Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal…
  675. FDA-2017-H-5003-0001Complaint
  676. FDA-2010-S-0664-2673Perrigo - GoodSense Century - Support for Prostate and Colon Health
  677. FDA-2014-P-0814-0018Exhibit 20 O'Riordan, M. After Patient's Death, Study Shows HCV Drug Cardiotoxic in 14 of…
  678. FDA-2011-S-0932-0820NBTY, Inc. (Shop Rite Calcium Plus Vitamin D Supplements) Primary Mineal Responsible for…
  679. FDA-1994-D-0055-0001FDA
  680. FDA-2021-V-0159-0002Acknowledgment Letter from FDA DMS to Audio Advice
  681. FDA-2025-S-0024-08842025-000959 - Hyperlife Nutritionals Inc - FitRx, Yerba Maté Fiber Tablets - Regulating…
  682. FDA-1982-G-0253-0014Letter from FDA CFSAN to Devro, Inc.
  683. FDA-2002-N-0060-0003Agency Information Collection Activities; Announcement of Office of Management and Budget…
  684. FDA-2019-D-2330-0002Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Guidance…
  685. FDA-2008-N-0038-0071Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug…
  686. FDA-2007-N-0220-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  687. FDA-2011-S-0932-0803L. G. Sciences, L. L. C. (L. G. Sciences Form-X, Rezolution & Substerone Supplements) We…
  688. FDA-2008-S-0664-0002NDI 423 - Vitamin D3 (Cholecalciferol) - Original NDI Notification
  689. FDA-2022-H-2082-0001Complaint
  690. FDA-2020-V-2206-0001Variance Application from Mark Plopper
  691. FDA-2018-N-1815-0108Tab C - FDA - Fluoride Bottled Water - FRIA (2021-253) as cleared OMB (version 2-14-22)
  692. FDA-2018-H-2952-0001Complaint
  693. FDA-2022-H-1169-0001Complaint
  694. FDA-2018-H-4896-0001Complaint
  695. FDA-2017-D-0175-0056Reference 49-FDA_Recalls Listeria mono in Sprouts_RES Database re Guidance for Industry on…
  696. FDA-2005-S-0518-0062NDI 275 - Wheat germ-derived ceramides - Original NDI Notifications
  697. FDA-2025-V-1118-0001Variance Application from Luminescent Lighting and Visuals
  698. FDA-2015-H-4411-0001CTP CMP Case re Ezequiel Food Corp. d/b/a Sabor Latino
  699. FDA-2023-S-0024-06802023-001418 - OLLY PBC - OLLY Maximum Strength Sleep - Supports Falling Asleep & Staying…
  700. FDA-2016-S-0024-0805Plexus Worldwide, LLC - Multiple claims - 8
  701. FDA-2021-N-0524-0002CDRH 09 17 21 Workshop Final Transcription
  702. FDA-2019-H-2510-0001Complaint
  703. FDA-2003-N-0028-0001FDA
  704. FDA-2015-S-0024-0452USANA Heath Sciences, Inc. - PhytoEstrin - Supports women's health
  705. FDA-2013-S-0024-0320Perrigo Company of South Carolina - Spring Valley®- Glucosamine Chondroitin - Joint Health
  706. FDA-2014-N-0001-0065Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
  707. FDA-1995-N-0063-0130Reference 42 Schwab et al Microbiological Quality of Dry-Milk Mixes and Milk Substitute…
  708. FDA-2019-V-1916-0002Acknowledgment Letter from FDA DDM to Carestream Dental LLC c/o Trophy
  709. FDA-2009-S-0607-1574Perrigo - CareOne® - Coenzyme Q-10 - Heart Health
  710. FDA-2024-V-0470-0001Variance Application from John Mcelligott
  711. FDA-2019-E-1181-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  712. FDA-2006-P-0347-0006Exhibit B1 - B3
  713. FDA-2021-S-0024-02622021-000345 Lang Pharma Nutrition Inc- CVS Health Cranberry+- support a healthy urinary…
  714. FDA-2016-V-2566-0001Variance Application from The Sandcastle Organization, Inc.
  715. FDA-2015-V-0750-0001Variance Application from Solotech Inc.
  716. FDA-2018-H-4038-0001Complaint
  717. FDA-2006-D-0300-0002Guidance
  718. FDA-1980-F-0041-0003Indirect Food Additives: Adhesive Coatings and Components; Vinylidene Chloride Copolymer…
  719. FDA-2015-H-0558-0001Complaint
  720. FDA-2003-E-0112-0006FDA/CDER to the U.S. Patent and Trademark Office
  721. FDA-2018-H-1306-0001Complaint
  722. FDA-2010-S-0664-2507North American Pharmacal, Inc. - Polyvite O - Multivitamin Nutrition Support for Blood…
  723. FDA-2025-S-0024-16212025-001744 - Shaklee Corporation - MULTIPLE CLAIMS (7)
  724. FDA-2010-P-0346-0001Apotex, Inc. - Citizen Petition
  725. FDA-2024-V-3530-0003Variance Approval Letter from FDA CDRH to Nash Cox
  726. FDA-2024-S-0024-02352024-000841 - Natrol LLC - Natrol® 5-HTP 100mg Capsules- Promotes production of serotonin
  727. FDA-2010-P-0130-0003Attachment III - "Proposed Draft Insert Labeling for Docetaxel Injection 20 mg/mL"…
  728. FDA-2003-P-0174-0048Background Material - A CBO Study 1998
  729. FDA-2025-V-3775-0001Variance Application from Laser Guys LLC
  730. FDA-2021-P-0576-0002Acknowledgment Letter to Husch Blackwell from FDA DMS
  731. FDA-2015-N-0001-0103Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
  732. FDA-1981-N-0245-0001Letter from FDA OC to West-Ward Pharmaceuticals Corp.
  733. FDA-2018-H-3269-0001Complaint
  734. FDA-2025-H-2809-0001Complaint
  735. FDA-2015-D-0235-0002Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga…
  736. FDA-2025-P-7006-0003Attachment 1
  737. FDA-2008-E-0266-0006Determination of Regulatory Review Period for Purposes of Patent Extension: DORIBAX
  738. FDA-2023-H-3191-0001Complaint
  739. FDA-1982-N-0011-0182Background Material
  740. FDA-2023-S-0024-08162023-001942 - Blueroot Health- Vital Nutrients, Lipoic Acid-support for cellular energy…
  741. FDA-2023-N-3902-0861Comment from Anonymous
  742. FDA-2023-H-3511-0001Complaint
  743. FDA-2011-V-0191-0002Acknowledgement Letter to Exclusive Entertainment Productions
  744. FDA-2022-P-1255-0003Tentative Response Letter from FDA CVM to Harry Duty
  745. FDA-2019-H-5652-0001Complaint
  746. FDA-2016-N-3118-0003Reference 2 - Draft Guidance on Methylphenidate Hydrochloride re Mallinckrodt…
  747. FDA-2016-N-0832-0044Exhibit 8 Expert Opinion of Robert D. Gibbons, Ph.D. re: Request for Hearing from Phibro…
  748. FDA-2015-H-3772-0001CTP CMP Case re MJ Mart, LLC
  749. FDA-2002-E-0284-0007United States Patent and Trademark Office - Letter With Attached Certificate
  750. FDA-2012-N-1210-0607Request for Extension from National Yogurt Association
  751. FDA-2017-H-0474-0001CMP Complaint from FDA CTP to Family Dollar Stores of Missouri, LLC d/b/a Family Dollar…
  752. FDA-2023-N-3902-1836Comment from Linda Johnson
  753. FDA-2014-N-0189-10094Request for Extension from Anonymous
  754. FDA-2014-H-2189-0001Complaint
  755. FDA-2015-P-0989-0013Tab 11 21CFR1240.61 Citizen Petition From Organic Pastures
  756. FDA-2024-R-2975-0001Complaint
  757. FDA-2018-P-3372-0008Final response from FDA CDRH to Ohio State University
  758. FDA-1985-V-0045-0001Center for Devices and Radiological Health - Nal1
  759. FDA-2014-P-1383-0005Attachment III Highlights of Prescribing Information
  760. FDA-2015-S-0024-2219Perrigo - CVS/pharmacy™ - Calcium & Vitamin D3 - Calcium is an essential mineral for…
  761. FDA-2021-S-0024-12262020-4321 Natural Organics - MULTIPLE CLAIMS (2)
  762. FDA-2006-M-0049-0001FDA
  763. FDA-2025-S-0024-07552025-000854 - FoodState - MegaFood, Omega-3 Fish Oil - Supports heart, brain, and immune…
  764. FDA-2019-H-5982-0001Complaint
  765. FDA-2003-M-0501-0002Premarket Approval Response Letter from FDA CDRH to Boston Scientific Scimed, Inc.
  766. FDA-2018-H-1409-0001Complaint
  767. FDA-2011-V-0700-0002Acknowledgement Letter to River Walk, LLC
  768. FDA-2013-S-0024-0971NOW Foods - Elderberry, Zinc & Echinacea Syrup - Healthy Immune Support
  769. FDA-2014-H-2145-0001Complaint
  770. FDA-2021-P-1113-0002Petition for Stay of Action from Prohibition Juice Company, LLC
  771. FDA-2023-V-1835-0003Variance Approval Letter from FDA CDRH to Alexander & Tom, Inc.
  772. FDA-1993-G-0218-0406Acknowledgment Letter from FDA/CFSAN to Canadian Harvest, U. S. A.
  773. FDA-2020-V-1799-0001Variance Application from Freed Sales Inc
  774. FDA-2007-D-0369-0511PSG_008720 - Draft Guidance on Levorphanol Tartrate
  775. FDA-2023-V-1978-0001Variance Application from Zejus, LLC
  776. FDA-2014-D-0055-0477Letter from CFSAN to SNAC International
  777. FDA-1977-N-0002-1796Answer Letter from FDA/Bureau of Veterinary Medicine to United States Department of the…
  778. FDA-1997-S-0006-0700HFS-456 to Jarrow Formulas, Inc. - Letter - Let 389
  779. FDA-2019-E-1944-0007Letter from FDA CDER to U.S. Patent and Trademark Office
  780. FDA-2017-H-6927-0001Complaint
  781. FDA-2007-P-0116-0005Dean Kantis - text file Addendum: Supplement to Dean A. Kantis Petition
  782. FDA-2018-N-0045-0001Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory…
  783. FDA-2019-H-3721-0001Complaint
  784. FDA-2021-S-0024-04252021-000629 Vista Outdoor Sales LLC - Go Condition, Prime Immunity - Assists faster…
  785. FDA-1977-N-0002-1397Answer Letter from FDA to Comment from Hodges Poultry Farm, Inc.
  786. FDA-1997-N-0040-0020Letter from American Society for Reproductive Medicine (ASRM)
  787. FDA-2004-N-0451-0048Food and Drug Administration Modernization Act of 1997: Modifications to the List of…
  788. FDA-2024-H-1321-0001Complaint
  789. FDA-2018-D-0481-0011Standardized Format for Electronic Submission of Marketing Application Content for the…
  790. FDA-2020-N-2002-0002Thomas J. Whalen: Final Debarment Order
  791. FDA-1999-S-4653-0020NDI 40 - Monacolin 8000F - Original NDI Notification
  792. FDA-2015-H-1588-0001Complaint
  793. FDA-2022-E-2143-0006Determination of Regulatory Review Period for Purposes of Patent Extension; VEKLURY
  794. FDA-2025-V-0404-0002Acknowledgment Letter from FDA DMB to Energy Science Unlimited
  795. FDA-2010-S-0664-2348Perrigo - H-E-B Complete - Convert Food to Fuel
  796. FDA-2019-N-5959-0016Reference 13 - Expert and Consumer Evaluation of Consumer Medication Information ‐ 2008 RE…
  797. FDA-2022-H-1236-0001Complaint
  798. FDA-2014-N-0504-0002Reference 10 - Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility…
  799. FDA-2019-V-0658-0002Acknowledgment Letter from FDA DDM to Continental Advanced Lidar Solutions
  800. FDA-2014-E-2372-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  801. FDA-1999-N-0113-0035Background Information
  802. FDA-2023-H-2409-0001Complaint
  803. FDA-2023-H-0458-0001Complaint
  804. FDA-2009-S-0607-0786Perrigo - Good Neighbor Pharmacy & GoodSense Calcium - For Bone & Colon Health
  805. FDA-2002-E-0120-0004FDA/CDER to the U.S. Patent and Trademark Office
  806. FDA-2017-S-0024-0115NOHO Health Inc. dba Care/Of 6, Evening Primrose Oil, beneficial for skin health
  807. FDA-2005-V-0143-0001HFA-305 to Black Oak Casino
  808. FDA-2000-P-0126-0054Salmas Law Group - Request for Extension Comment Due Date
  809. FDA-2014-V-0334-0001Variance Application from FineLine Multimedia
  810. FDA-2013-D-0811-0070Attachment 2 Roman, M. Micro-Biome Restorative Therapy: Successful treatment of Dogs and…
  811. FDA-2025-P-1576-0169Notice of Supplemental Authority from Massachusetts Attorney General's Office
  812. FDA-2005-P-0052-0006Miriam Provost, Ph.D., CDRH
  813. FDA-1976-N-0476-0370Memorandum of Telephone Conversation between Lowell Irminger (Adria) and Dr. P. D. Lepore…
  814. FDA-2016-Q-2646-0245IND CFSAN Vitamin D to Reduce MS Risk CDER Consult
  815. FDA-2014-N-1051-0419418 7694105 RDC CRF Subject R3010_Redacted
  816. FDA-2011-V-0193-0001Phong Le Co. - Application for Variance
  817. FDA-2019-N-0001-0008Statement of Organization, Functions, and Delegations of Authority
  818. FDA-2010-S-0664-0997Pure Essence Labs, Inc. - Ionic Fizz Super D-K Calcium Plus Orange-Vanilla - Support…
  819. FDA-2024-S-0024-08952024-001770 - Beiture LLC - Beiture NR ResCo, Nicotinamide Riboside (NR) Resveratrol…
  820. FDA-2016-Q-2646-0051Reference 47 from Health Claim Petition- Miller, D.H. et al. (2012) re Qualified Health…
  821. FDA-1984-N-0259-0249Response to Motion from Roxane Laboratories, Inc.
  822. FDA-2011-N-0013-0005Statement of Organizations, Functions, and Delegations of Authority
  823. FDA-2011-N-0103-0004Reference 2 - Abshire, T.G. et at, "Validation ofthe use of gamma phage for identifying…
  824. FDA-2012-S-1144-1785NBTY Inc - Bromelain Boswella Complex - Supports Joint Health
  825. FDA-2017-E-5106-0008Letter from Eli Lilly and Co. (Hogan Lovells) to FDA DDM
  826. FDA-2008-P-0380-0008National Consumers League, et al (Olson, Frank, Weeda) - Withdrawal of Petition
  827. FDA-2010-E-0663-0007U.S. Patent and Trademark Office to Bookof & McAndrews - Letter
  828. FDA-1997-N-0010-0031Attachment 0 - "PBSC Product Case Summaries (Aug1999 - Dec2003) [National Marrow Donor…
  829. FDA-2001-N-0178-0036Tab B Changes of Initial Draft (FRN 70FR33998) Submitted to OMB OIRA for Review and Action…
  830. FDA-2017-H-2926-0001CMP Complaint Issued to Gary Hutchinson and Fabain Pinnok d/b/a G and F Grocery
  831. FDA-2025-P-4987-0001Suitability Petition from Athyna Pharma LLC
  832. FDA-2019-E-3278-0013Response to Request for Information Pursuant to 37 C.F.R. 1.750
  833. FDA-2011-S-0932-1545RKS, Inc. - Premium Nutrition LifeCal, HyCal & Life Cal-Mag - Helps Support Cardiovascular…
  834. FDA-2014-V-0922-0007Variance Approval from FDA CDRH to Advanced Entertainment Technologies DBA Image…
  835. FDA-2018-P-4851-0007Acknowledgment letter from FDA DDM to Hetero Labs Limited
  836. FDA-2012-V-0768-0003FDA/CDRH to Elev8d LLC - Variance Approval
  837. FDA-2021-S-0024-02072021-000232 Jarrow Formulas Inc - Jarrow Formulas CURCUMIN PHYTOSOME - Supports…
  838. FDA-2001-Q-0085-0007Appendix 2 Environ Report: Estimated Intake of Fiber by Consumers of Products Proposed…
  839. FDA-2022-P-0558-0002Acknowledgment Letter from FDA DMS to Novitium Pharma LLC
  840. FDA-1980-N-0038-0160Certain topical anti-infective drug products; drugs for human use; drug efficacy study…
  841. FDA-2017-H-0510-0001CTP CMP Complaint to Stop-One Food Mart and Tobacco Shop, LLC d/b/a Stop-One Food Mart
  842. FDA-2011-S-0932-0864NBTY, Inc. (Major Folic Acid Supplements)
  843. FDA-2022-S-0024-02732022-000266 - Lang Pharma Nutrition Inc. - CVS Health Brain Function & Alertness…
  844. FDA-2004-P-0333-0002Notice of Final Rule- Medical Devices; Immunology and Microbiology Devices; Classification…
  845. FDA-2015-S-0024-0647NBTY, Inc. - Herbal Digestive Blend - Helps with stomach discomfort
  846. FDA-2012-S-1144-0259NBTY, Inc. - B-50(Radiance label) - Supports Nervous System Health and Energy Metabolism
  847. FDA-1980-N-0049-0067Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf
  848. FDA-1977-N-0014-0491Letter from R. D. Grant and Robert L. Turner to Honorable Richard A. Gephardt, House of…
  849. FDA-1997-S-0006-0018[LET713] CFSAN/ONLDS Response to Tabak's Health Products - Courtesy Letter
  850. FDA-1997-P-0417-0007Letter from FDA/CDER to McKenna & Cuneo, L.L.P.
  851. FDA-2019-H-0166-0001Complaint
  852. FDA-1978-N-0018-0219FDA
  853. FDA-2017-N-1064-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
  854. FDA-2014-N-0189-4804Request for Extension from Anonymous
  855. FDA-2015-H-3886-0001CTP CMP Case re OHM Farm Store Inc. d/b/a Discount Drive Thru
  856. FDA-2008-N-0334-0009Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission…
  857. FDA-1984-D-0028-0003Background Material
  858. FDA-2012-S-1144-0253NBTY, Inc. - Radiance DHEA Supplements - May Support Sugar Metabolism
  859. FDA-2009-S-0607-1316Perrigo - Dolgencorp, LLC DG Health Complete - Support Immune System Health
  860. FDA-2022-S-0024-01792022-000168 - Factors Group of Nutritional Companies Inc - webber naturals, flaxseed oil…
  861. FDA-2016-V-2943-0006Supplement to Variance from Garmin International, Inc.
  862. FDA-2011-N-0279-0010Agency Information Collection Activities; Announcement of Office of Management and Budget…
  863. FDA-2014-N-0189-4873Request for Extension from Jacob Wynn
  864. FDA-2015-S-0024-2344NBTY, Inc. - Fish Oil - Heart support
  865. FDA-2025-N-1927-0002GRAS (GRN) Notice 1161 Amendments
  866. FDA-2016-P-1213-0004Attachment 2 Draft labeling for the proposed product, Goody's Migraine re Citizen Petition…
  867. FDA-2003-N-0095-0009Medical Review
  868. FDA-2020-D-0957-0115115-[510(k)]-Submissions-for-Testing-for-Skin-Sensitization-To-Chemicals-In-Natural-Rubber
  869. FDA-2013-V-0050-0001Pulse Stage Lighting - Application for Variance
  870. FDA-2015-S-0024-2527Perrigo Company - Perrigo®- Vision Shield® - Vitamin C, Vitamin E and Zinc are…
  871. FDA-2023-S-0024-05072023-001015 - Zarbees Inc. - Zarbee's Inspired By Nature [3yr to 12yr+] [Childreen's Sleep…
  872. FDA-2015-H-4780-0001CTP CMP Case re JC Mini Market, Inc. d/b/a J.C. Mini Market and Deli
  873. FDA-2014-E-0943-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  874. FDA-2003-N-0253-0005FDA
  875. FDA-2017-H-0713-0001CMP Complaint from FDA CTP to Rio Plantation Fuel, Corp. d/b/a RP Fuel
  876. FDA-2018-P-3401-0009Agency Response Letter from FDA CDER to Novo Nordisk, Inc.
  877. FDA-2018-S-0024-02282018001395 - International Vitamin Corporation - MULTIPLE CLAIMS (4)
  878. FDA-2018-P-1352-0004Appendix 3 - A marked up copy of the package insert showing Felix's proposed changes re…
  879. FDA-1997-S-0006-0753HFS-810 to Vitamania - Letter - Let 442
  880. FDA-2012-N-0001-0135Cellular, Tissue and Gene Therapies Advisory Committee Meeting
  881. FDA-1998-P-0838-0003Petition Approval FDA-1998-P-0038
  882. FDA-2005-D-0457-0004Guidance
  883. FDA-2020-P-0512-0001Citizen Petition from Hyman, Phelps, & McNamara PC
  884. FDA-2016-N-3120-0145redacted_095_Memo Pharmacovigilance Activity
  885. FDA-2022-H-1901-0001Complaint
  886. FDA-2025-V-0413-0003Variance Approval Letter from FDA CDRH to Neg Earth Lights Limited
  887. FDA-2024-D-2442-0005Reference 3 - CCP guidance -COVID-19 Vaccines _ FDA
  888. FDA-1975-N-0017-0011Memorandum from FDA/CDER to FDA DDM
  889. FDA-2014-P-0511-0004Gablofen/Baclofen Petition Close out Memorandum from CDER Director
  890. FDA-1996-N-0028-0319Tab 3 - "Part A General Provisions" - [American Labs., Inc. (ALI) – Comment] re…
  891. FDA-2011-P-0025-0003FDA/CDER Interim Response to Olsson Frank Weeda Terman Bode Matz PC - Letter
  892. FDA-2021-D-0775-0001Content of Premarket Submissions for Device Software Functions; Draft Guidance for…
  893. FDA-2022-P-3257-0006Attachment 4 - Our Current Understanding of the Human Health and Environmental Risks of…
  894. FDA-2011-S-0932-1149Schwabe North America, Inc. (Schwabe Thisilyn Cleanse Mineral Supplements)
  895. FDA-2015-S-0024-2952Perrigo - Meijer™ - promotional - Vitamin E is an antioxidant. It works to protect cell…
  896. FDA-2018-H-3181-0001Complaint
  897. FDA-2022-S-0024-01722022-000154 - Wile Inc - 1- Wile 40+ Period Support - Improved energy and clarity
  898. FDA-2015-H-1099-0001Complaint
  899. FDA-2005-N-0343-0037April 10 2006 Federal Register for Medical Gas Containers and Closures_ Current Good…
  900. FDA-2023-H-4993-0001Complaint
  901. FDA-2011-S-0932-0795Nature's Instincts, Inc. (Nature's Instincts Stemulite II for Men AM Supplements) Natural…
  902. FDA-1997-S-0006-0535HFS-456 to Continental Vitamin Co. Inc. - Letter - Let 244
  903. FDA-2018-N-4626-0179Nomination from Wedgewood Pharmacy
  904. FDA-2025-P-1143-0091Background Material from Martinez Alvarez, Jhon Jairo Antonio
  905. FDA-2018-H-4873-0001Complaint
  906. FDA-2017-H-3880-0001CMP Complaint Issued to Smith Package LLC d/b/a West Side Liquor
  907. FDA-1997-S-0006-1977Courtesy letter and related material from CFSAN to TSI USA, LLC
  908. FDA-1975-N-0012-0819Lonza Inc. Listing 16.2.6.1: Hand Wash and Packaging Weights Details Safety Population…
  909. FDA-2021-V-0120-0003Variance Approval Letter from FDA CDRH to EOC Audio
  910. FDA-2015-V-0920-0002Acknowledgement Letter from FDA DDM to EEG
  911. FDA-2017-H-0525-0001CTP CMP Complaint to Supermercado H and W, Inc. d/b/a Econo
  912. FDA-2025-P-4155-0001Citizen Petition from C. Humphrey & Associates, P.A.
  913. FDA-2020-V-0349-0002Acknowledgment Letter from FDA DMS to Alford Media Services LLC
  914. FDA-2022-H-1877-0001Complaint
  915. FDA-2007-P-0122-0047Federal Trade Commission
  916. FDA-2016-N-1111-1712Attachment 9 Police Report Canton Police Department re: Supplemental Comment from Eckert…
  917. FDA-1997-N-0041-0022Acknowledgement Letter to Jerome Stevens Pharamceuticals
  918. FDA-2022-S-0024-09022022-000942 - Steeped Fine Loose Teas Accessories Co. - Sipology Heal-thy Self, WEIGHT…
  919. FDA-2025-P-2526-0071Reference 69 - Lindbohm ML, et al. (2007) Occupational exposure in dentistry and…
  920. FDA-2010-D-0249-0004Guidance for Industry; Systemic Lupus Erythematosus — Developing Medical Products for…
  921. FDA-1977-N-0014-1326Answer from FDA/Office of Legislative Services to Comment from the Honorable Dan Daniel…
  922. FDA-2015-D-3581-0002Draft Guidance Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based…
  923. FDA-2024-H-1899-0001Complaint
  924. FDA-2016-S-0024-1780NBTY - Vitamin E supplements - Supports immune health
  925. FDA-2023-H-3146-0001Complaint
  926. FDA-2011-S-0932-2040Arbonne International, LLC - Arbonne Essentials Digestion Plus - Enzymes help support…
  927. FDA-2021-V-0396-0003Approval Letter from FDA CDRH to One Source LLC
  928. FDA-2024-H-4070-0001Complaint
  929. FDA-2024-N-5471-0916PRIA Reference 247 Office of Management and Budget Circular A 4 2023
  930. FDA-2020-H-0335-0001Complaint
  931. FDA-2019-H-0998-0001Complaint
  932. FDA-2018-N-4626-0822Nomination from Wedgewood Pharmacy
  933. FDA-2018-H-2151-0001Complaint
  934. FDA-1981-N-0083-0036Center for Science in the Public Interest - Letter
  935. FDA-2017-H-5709-0001Complaint
  936. FDA-2020-S-0024-1232SFC2020-001408 Matys Healthy Products- Men's Multi Capsules- MAINTAIN STRONG BONES
  937. FDA-2017-H-6567-0001Complaint
  938. FDA-2017-V-3967-0003Variance Approval Letter from FDA CDRH to GOLDEN NUGGET CASINO ATLANTIC CITY
  939. FDA-2015-P-3410-0001Citizen Petition from David K Cundiff
  940. FDA-2014-V-0657-0002Variance Application from Trophy (Carestream Dental Company)
  941. FDA-2025-P-5921-0033Reference 15
  942. FDA-2021-S-0024-00342021-000034- Bulletproof 360 Inc - Bulletproof, Sleep - Supports better quality sleep
  943. FDA-2005-N-0094-0037Electronic Request for Appearance for Marcarelli, Mike
  944. FDA-2016-S-0024-0890Natrol - Skin, Hair & Nails - Improves skin elasticity & hydration with Lutein
  945. FDA-2003-N-0045-0002See FDA-2003-N-0045-0085
  946. FDA-2007-P-0234-0004FDA/CDER Interim Response to Terence J. Mix
  947. FDA-2004-D-0498-0003Guidance
  948. FDA-2013-V-0179-0002Acknowledgement Letter to DJ ICE
  949. FDA-2021-V-1055-0001Variance Application from EOS Lounge
  950. FDA-2021-P-0339-0001Citizen Petition from Gland Pharma Limited
  951. FDA-2008-P-0134-0001Lachman Consultant Services, Inc. - Citizen Petition
  952. FDA-2009-P-0424-0003FDA/CFSAN to Fuerst, Humphrey, Ittleman, PL - Petition Denial
  953. FDA-2020-V-1872-0001Variance Application from Dylan Todd
  954. FDA-2006-P-0007-0051Petition Partial Approval and Denial from FDA/CDER to ViroPharma Inc.
  955. FDA-2007-D-0369-0804PSG_208232 - Draft Guidance on Octreotide Acetate re Product-Specific Guidances; Draft and…
  956. FDA-2024-H-4137-0001Complaint
  957. FDA-2009-S-0607-1379NBTY, Inc. - Bulgarian Tribulus - Perfect Complement to Your Hard-Core Training Regimen
  958. FDA-2012-V-0402-0003FDA / CDRH Response to Nocturnal Productions - Approval for Variance
  959. FDA-2019-H-2764-0001Complaint
  960. FDA-2013-P-0735-0004Appeal From Mario Morais
  961. FDA-2015-V-0027-0003Variance Approval from FDA CDRH to DOCTOR DEE'S DJ SERVICE
  962. FDA-2017-H-4230-0001CMP Complaint Issued to Casino Center 61, LLC d/b/a Casino Center II / Exxon
  963. FDA-2013-V-1130-0002Acknowledgement Letter to Made Up LTD
  964. FDA-2011-S-0932-2925Genexis - Inflama-Free - Supports Healthy Inflammation Response
  965. FDA-2016-S-0024-0599Perrigo Company - Promotional - B-Vitamins and Iron facilitate cellular energy production
  966. FDA-2009-V-0469-0002Variance Approval from FDA CDRH to L-3 Communications Wescam
  967. FDA-2018-H-3787-0001Complaint
  968. FDA-2024-H-3030-0001Complaint
  969. FDA-1978-N-0018-0181FDA
  970. FDA-2024-H-4323-0001Complaint
  971. FDA-2020-H-0281-0001Complaint
  972. FDA-2018-H-4913-0001Complaint
  973. FDA-2019-E-2092-0006Letter to U S Patent and Trademark Office
  974. FDA-2015-N-0002-0059New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
  975. FDA-2023-H-4207-0001Complaint
  976. FDA-2014-N-0001-0055Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
  977. FDA-2019-H-4122-0001Complaint
  978. FDA-2002-S-0531-0039NDI 114 - BioDiamed (Mormadica charantia L.) from Kelatron Corporation World Headquarters
  979. FDA-2017-H-5855-0001Complaint
  980. FDA-2023-H-0090-0001Complaint
  981. FDA-2025-H-2599-0001Complaint
  982. FDA-2019-S-0024-08482019-002651 - New Chapter - Fermented B Complex - Supports Energy, Beauty, Brain & Nervous…
  983. FDA-2021-N-1309-0079Reference 76 Klausner Menthol Cigarettes and Smoking Initiation 2011
  984. FDA-1997-S-0039-2728Perrigo - HEALTHsense - Complete - Vitamin A - helps maintain healthy skin and hair
  985. FDA-2013-N-0227-0143Reference 74 Durmowicz The Impact of Electronic Cigarettes on the Pediatric Population…
  986. FDA-2010-N-0013-0025Reference 24 - "What You Need to Know About Establishment and Maintenance of Records"…
  987. FDA-2016-H-3344-0001Complaint
  988. FDA-2013-P-1203-0002Acknowledgement Letter to McGuireWoods LLP
  989. FDA-2019-H-1894-0001Complaint
  990. FDA-2003-E-0264-0004HFD-005 to U.S. Patent & Trademark Office
  991. FDA-2002-N-0033-0003Notice of Proposed Rule Making from FDA/CFSAN re Bioterrorism Preparedness; Administrative…
  992. FDA-2019-H-4542-0001Complaint
  993. FDA-2023-H-2651-0001Complaint
  994. FDA-2018-V-0300-0003Approval Letter from FDA CDRH to PAUL HUTCHINSON
  995. FDA-2007-E-0400-0006Exhibit 2 re Patent Term Extension Application from ALZA Corporation, FDA-2007-E-0400-0004
  996. FDA-2022-H-0334-0001Complaint
  997. FDA-2016-N-3120-0072redacted_056_Pharmaco Memo Attachment
  998. FDA-2016-N-0001-0069Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee…
  999. FDA-2025-H-1392-0001Complaint
  1000. FDA-2009-N-0383-0004Request for Nominations on the Tobacco Products Scientific Advisory Committee

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