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Regulations.gov documents

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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2017-P-6208-0005.

  1. FDA-2010-S-0664-0433Genexis - Lycopene - Offers Powerful Antioxidant Protection
  2. FDA-2011-D-0689-0002Draft Guidance for Industry and Staff; De Novo Classification Process (Evaluation of…
  3. FDA-1991-G-0159-0030Environmental Assessment
  4. FDA-1980-N-0067-0014Memorandum from Charles Ganley (HFD-560) to Dockets Management Branch (HFD-305)…
  5. FDA-2014-V-0048-0001Variance Application from Studio Paris
  6. FDA-2002-N-0229-0002Agency Information Collection Activities; Submission for OMB Review; Comment Request…
  7. FDA-2009-S-0607-0655Indiana Botanic Gardens, Inc. - Conjugated Linoleic Acid (CLA) - Help Stop the Weight from…
  8. FDA-2016-P-1163-0089Exhibit 41 HH Popper. Etiology, pathogenesis and differential diagnosis of lung…
  9. FDA-2016-P-0135-0004Letter from Hyman, Phelps & McNamara, P.C. to FDA withdrawing Petition
  10. FDA-1997-N-0152-0054FDA/USDA TownMeeting on Microbial Risks for Fresh Produce, December 8, 1997 - Transcript
  11. FDA-1980-P-0073-0012FDA/CDRH Response to Coherent Innovations Inc - Approval of Variance
  12. FDA-2020-D-1362-0001Draft Guidance for Industry; Regulatory Submissions to OFAS, Part VI GRAS Notices
  13. FDA-2014-H-0317-0001Complaint
  14. FDA-2014-N-1051-0546545 7694105 RDC CRF Subject R4105_Redacted
  15. FDA-2021-S-0024-01082021-000122 Xyngular - Cheat - helps control appetite
  16. FDA-2025-H-7382-0001Complaint
  17. FDA-2007-N-0363-0038Withdrawn
  18. FDA-2022-V-1614-0003Variance Approval Letter from FDA CDRH to HD Media Systems
  19. FDA-2022-V-1673-0001Variance Application from Benjamin Shaver
  20. FDA-2014-S-0024-0122Perrigo Company Sound Body One Daily Letter
  21. FDA-2014-N-0189-6233Request for Extension from Mike Skoog
  22. FDA-2010-N-0248-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Format…
  23. FDA-2014-N-0189-4877Request for Extension from Anonymous
  24. FDA-2007-D-0369-2401PSG_009829 - Draft Guidance on Pyridostigmine Bromide
  25. FDA-2025-H-1616-0001Complaint
  26. FDA-2025-H-3992-0001Complaint
  27. FDA-2025-V-5803-0001Variance Application from Intelligent Light | Sound | Video
  28. FDA-2021-P-0923-0005Agency Response Letter from FDA CDER to Gland Pharma Limited
  29. FDA-2000-P-0568-0001State of Alaska Department of Environment Conservation - Citizen Petition
  30. FDA-2023-P-0793-0009Tab 7 - Office of Clinical Pharmacology Review MAYZENT NDA 209884 re Citizen Petition from…
  31. FDA-2017-H-0481-0001Complaint from FDA CTP to Greig Store LLC d/b/a Greig Store
  32. FDA-2024-S-0024-06902024-001531 - Doctors Best LLC - Doctor's Best, Women’s Digestive Probiotic Prebiotic With…
  33. FDA-1997-S-0039-0941PuraPharm International Ltd. - Zhen Wu Tang
  34. FDA-2006-N-0418-0004Background Material re Medical Devices; Anesthesiology Devices; Neurological Devices…
  35. FDA-2016-H-2715-0001Complaint
  36. FDA-2009-N-0380-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Product…
  37. FDA-2009-N-0483-0003Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical…
  38. FDA-2023-H-1718-0001Complaint
  39. FDA-2009-S-0607-0185Planetary Herbals - Vita Greens and Berries - Antioxidant Defense, Immune Health, Healthy…
  40. FDA-2025-H-1963-0001Complaint
  41. FDA-2022-H-2509-0001Complaint
  42. FDA-1980-N-0074-0030Memorandum of Telephone conversation Between Church & Dwight Co. Representatives & OTC…
  43. FDA-2007-P-0234-0013Terence J. Mix, Esq. - Supplement
  44. FDA-2023-H-1491-0001Complaint
  45. FDA-2017-P-4575-0031Reference 24 - Effects of Aragan and Olive Oil Consumption on the Hormonal Profile of…
  46. FDA-2025-H-0106-0001Complaint
  47. FDA-2011-S-0932-0573Letter from NBTY, Inc.
  48. FDA-1994-P-0041-0228HFS-830 adn Cargill Specialty Oils
  49. FDA-1996-N-0028-0459Reference 43 - "Presidential Memorandum on Plain Language, The White House, Washington…
  50. FDA-2010-S-0664-0289Lang Naturals, Inc. - DHA Omega-3 Multi, Women's 50+ Advanced - Supports Breast Health
  51. FDA-1997-S-0039-1264Letter from Perrigo Company of South Carolina
  52. FDA-2024-H-4828-0001Complaint
  53. FDA-2003-N-0386-0004National Agency of Vigilancia Sanitaria (ANVISA), Brasil
  54. FDA-2012-S-1144-2491EuroPharma Inc - Pancreatin - Supports healthy digestion of proteins, carbohydrates, and…
  55. FDA-2022-E-0941-0006Letter from U. S. Patent and Trademark Office
  56. FDA-2016-S-0024-1750Perrigo Co - Shopko® - Eye Health & Lutein - Formula ted with key nutrients to help…
  57. FDA-2011-S-0932-0154Letter from NBTY, Inc.
  58. FDA-2022-V-2288-0001Variance Application from Thee Doll House
  59. FDA-2011-P-0397-0001NewMarket Pharmaceuticals, LLC - Citizen Petition
  60. FDA-2008-N-0306-0001Preparation for International Cooperation on Cosmetics Regulations Meetings in Washington…
  61. FDA-2019-H-4803-0001Complaint
  62. FDA-2015-H-4568-0001CTP CMP Case re Y J Lim Inc. d/b/a Montbello Liquor
  63. FDA-2009-N-0263-0006Agency Information Collection Activities; Proposals, Submissions, and Approvals
  64. FDA-2007-E-0103-0011Letter from U.S. Patent Trademark Office re IONSYS (Fentanyl Iontophoretic Transdermal…
  65. FDA-2024-N-3655-0001Medical Devices; Immunology and Microbiology Devices; Classification of the Device To…
  66. FDA-2002-D-0187-0002FDA
  67. FDA-2019-H-0014-0001Complaint
  68. FDA-2015-H-1060-0001Complaint
  69. FDA-2020-D-0957-005049-guidance-content-premarket-notification-510k-submissions-hypodermic-single-lumen-needle…
  70. FDA-1977-N-0002-1188Answer Letter from FDA/Office of Legislative Services to L. A. Dell'Orco
  71. FDA-1977-N-0002-1463Answer Letter from FDA to Comment from The Honorable Harold Runnels, United States House…
  72. FDA-1986-P-0021-0002COPY- Petitions Requesting Exclusivity for Certain Chlorhexidine Gluconate Products
  73. FDA-2012-E-0196-0002U.S. Patent and Trademark Office - Letter
  74. FDA-2025-H-2234-0001Complaint
  75. FDA-2022-H-1787-0001Complaint
  76. FDA-2012-V-0878-0003FDA/CDRH to Coherent Laser Entertainment - Letter
  77. FDA-2004-N-0451-0044Food and Drug Administration Modernization Act of 1997: Modifications to the List of…
  78. FDA-2012-S-1144-2345NOW Foods - Chromium Picolinate - Supports Healthy Glucose Metabolism
  79. FDA-1984-N-0259-0519Exhibit G-7.13 re: Disclosure of Data and Information from Center for Drugs and Biologics
  80. FDA-2025-S-0024-16002025-001723 - Swanson Health Products - Swanson Health Products, Black Cohosh - Women's…
  81. FDA-2020-M-0984-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  82. FDA-2015-D-0838-0013Procedures for Meetings of the Medical Devices Advisory Committee; Guidance for Industry…
  83. FDA-2023-V-2756-0001Variance Application from Triton Productions US LLC
  84. FDA-2023-N-3902-0793Comment from John Stith
  85. FDA-2009-D-0528-0001International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of…
  86. FDA-2017-H-5145-0001Complaint
  87. FDA-2021-N-1349-0336PRIA Reference 27 HHS The Health Consequences of Involuntary Exposure to Tobacco Smoke…
  88. FDA-2016-D-4436-0005Bone Anchors—Premarket Notification (510(k)) Submissions; Guidance for Industry and Food…
  89. FDA-1994-V-0006-0005FDA/CDRH Response to Surefire, LLC - Approval of Variance
  90. FDA-2015-V-4100-0002Acknowledgement Letter from FDA DDM to Dimensions of Sound
  91. FDA-2008-D-0128-0006Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What…
  92. FDA-2003-N-0043-0002Agency Information Collection Activities; Announcement of Office of Management and Budget…
  93. FDA-2009-E-0056-0008USPTO Notice of Final Determination - Letter
  94. FDA-2010-P-0574-0006Interim Response Letter from FDA CDER to Beckloff Associates (Azur Pharma International…
  95. FDA-2018-S-0024-01712018001335- Ortho Molecular Products, Inc.- Digestzyme-V- supports Gastrointestinal Health
  96. FDA-2025-H-1636-0001Complaint
  97. FDA-2012-S-1144-1712Perrigo Company of South Carolina - Western Family®-Complete - Helps Support a Healthy…
  98. FDA-2014-P-0407-0007Interim Response from FDA/CDER to Almatica Pharma, Inc.
  99. FDA-1997-S-0039-2701Perrigo Company of South Carolina - Publix-Calcium Magnesium & Zinc- Calcium is an…
  100. FDA-2018-H-4379-0001Complaint
  101. FDA-2015-S-0024-0165NBTY Inc - DHA supplements - Supports cellular and metabolic health
  102. FDA-2020-N-1934-0001Virtual Public Meeting on Patient-Focused Drug Development for Systemic Sclerosis
  103. FDA-2022-N-2390-0359Exhibit 37 - FDRR I (Jan. 3, 2020)
  104. FDA-2022-D-0278-0001Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for…
  105. FDA-2020-P-0725-0011Interim Response letter from FDA CDRH to GBUK Group Ltd
  106. FDA-1977-N-0002-0652Routing Slip re: Comment from Bacterial Diseases Division to Public Health Research
  107. FDA-2007-P-0114-0003Citizen Petition from B. Braun Medical, Inc.
  108. FDA-1977-N-0014-1293Answer from FDA to Comment from Honorable Millicent Fenwick Congress of the United States
  109. FDA-2022-H-3055-0001Complaint
  110. FDA-2007-D-0369-1953PSG_050725 - Draft Guidance on Amoxicillin; Clavulanate Potassium
  111. FDA-2015-N-0101-0471Reference 11-244 - FDA-1975-N-0012-0231 --- LET25…
  112. FDA-2024-H-3438-0001Complaint
  113. FDA-1993-F-0116-0006Reference 1 U.S. Army Natick RD & E Center, "Space Food Prototype, Production Guide No…
  114. FDA-2011-V-0845-0001SandBar - Application for Variance
  115. FDA-2013-S-0024-0893Limitless Worldwide, LLC - SeroDyne Dietary Supplement - Supports Pituitary Health
  116. FDA-2008-N-0397-0004Agency Information Collection Activities; Announcement of Office of Management and Budget…
  117. FDA-2009-E-0240-0004FDA/CDER to the U.S. Patent and Trademark Office - Letter
  118. FDA-2013-P-1612-0049Acknowledgement Letter from FDA/DDM to Lee Wilson
  119. FDA-2020-D-1380-0005Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products…
  120. FDA-2014-N-0189-10768Request for Extension from Chris
  121. FDA-2023-E-3238-0002Patent Extension Application from Clark & Elbing LLP (on behalf of Genentech, Inc.)
  122. FDA-2008-E-0113-0019FDA/CDER to the U.S. Patent and Trademark Office - Letter
  123. FDA-2015-V-1384-0001Variance Application from Chad Messina
  124. FDA-1976-N-0476-0555Memorandum of Telephone Conversation between Patricia Richards (Fisonf Corporation) and…
  125. FDA-2014-N-0189-7262Request for Extension from Anonymous
  126. FDA-2016-H-2461-0001Complaint
  127. FDA-2008-P-0625-0006Acknowledgement Letter to ISTA Pharmaceuticals, Inc.
  128. FDA-2017-H-2366-0001CMP Complaint Issued to Esha Corporation d/b/a Carter’s 2 / Exxon
  129. FDA-2023-V-3974-0003Variance Approval Letter from FDA CDRH to Tali Cook
  130. FDA-2022-P-0475-0003Response Letter from FDA CDER to Lachman Consultant Services, Inc.
  131. FDA-2006-D-0410-0014Center for Devices and Radiological Health
  132. FDA-2016-H-1464-0001Complaint
  133. FDA-1995-N-0054-13848Background Material for NFR 1
  134. FDA-2011-P-0186-0004Acknowledgement Letter to Nexus Pharmaceuticals, Inc.
  135. FDA-2015-S-0024-0126NBTY Inc - Psyllium Seed Husk supplements - Digestive care
  136. FDA-2018-N-2904-0001Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on…
  137. FDA-2008-D-0143-0001Compliance Policy Guide Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1…
  138. FDA-2025-H-3106-0001Complaint
  139. FDA-2019-E-5820-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  140. FDA-2002-N-0316-0002Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP…
  141. FDA-1980-N-0038-0450Certificate of Service
  142. FDA-2018-S-0023-0159NDI 1102 - Dried, grated, sterilized fruit of Tetrapleura tetraptera - Original NDI…
  143. FDA-2022-H-0605-0001Complaint
  144. FDA-2023-N-3902-1816Comment from Tyson Canty
  145. FDA-2017-H-0936-0001CMP Complaint Issued to Fresh Start Convenience Stores, Inc. d/b/a Fresh Start
  146. FDA-2005-D-0461-0004Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for…
  147. FDA-2024-E-0478-0003Letter from FDA CDER to U. S. Patent and Trademark Office
  148. FDA-2010-N-0001-0031Food and Drug Administration/Xavier University Global Medical Device Conference
  149. FDA-2017-P-5082-0011Supplement from Sheldon Bradshaw, King & Spalding LLP
  150. FDA-2022-S-0024-04632022-000460 - Viva Naturals Inc. - Viva Naturals Inc, Elderberry, Vitamin C Zinc 4in1…
  151. FDA-2025-V-3780-0001Variance Application from El Cartel de Los Angeles Entertainment, Inc. DBA Worms Music
  152. FDA-1987-F-0123-0004Indirect Food Additives: Polymers
  153. FDA-2021-S-0024-04442021-000647 New Generation Wellness, Inc. - Zinc Picolinate 30 mg Caps - supports healthy…
  154. FDA-2025-H-6317-0001Complaint
  155. FDA-2019-H-3692-0001Complaint
  156. FDA-2015-H-4488-0001CTP CMP Case re ALCHH LLC d/b/a Airport Deli Mart
  157. FDA-2018-H-0108-0001Complaint
  158. FDA-2013-N-1524-1851Nomination Letter Diltiazem Hydrochloride USP re: Comment from Fagron
  159. FDA-2024-H-1814-0001Complaint
  160. FDA-2004-N-0258-0167Reference 30 - Methodolgy used to determine RACCs re Food Labeling: Serving Sizes of Foods…
  161. FDA-1997-N-0020-0019Reference 4 - Notification for New Use of a Food Contact Substance, FDA Form No. 3480…
  162. FDA-2012-N-0021-0010Agency Information Collection Activities; Submission for Office of Management and Budget…
  163. FDA-2008-D-0178-0027Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals…
  164. FDA-1997-S-0039-0849Perrigo Company of South Carolina - Kroger® - Glucosamine with Calcium + D - Bones &…
  165. FDA-2004-S-0571-0173NDI 233 - Cotinine - SUPPORTING & RELATED MATERIALS
  166. FDA-2005-C-0416-0001FDA
  167. FDA-2018-H-0429-0001Complaint
  168. FDA-2001-D-0066-0002Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims…
  169. FDA-2021-N-0471-0059Reference 76 Chhetri 2018 Effect of surrounding vegetation on microbial survival or…
  170. FDA-2025-H-6105-0001Complaint
  171. FDA-1990-N-0002-0003FDA
  172. FDA-2014-N-1051-0892Reference 3 ATTACHMENT_2A_MR0000041_MAR_11_2015_Redacted re Modified Risk Tobacco Product…
  173. FDA-2022-E-0930-0001Patent Term Extension Letter from U.S. Patent and Trademark Office to FDA CDER
  174. FDA-2016-D-2335-1699FRIA Reference 34 Muth et al 2016
  175. FDA-2021-N-0286-0013PRIA REFERENCE 11 SBA Size Standards Table 2016
  176. FDA-2019-H-4926-0001Complaint
  177. FDA-2011-S-0932-1658Vitacost.com, Inc., d/b/a Nutraceutical Sciences Institute - NSI® Eyebright Vision Complex…
  178. FDA-2024-V-1487-0002Acknowledgment Letter from FDA DMS to Lucidum, LLC.
  179. FDA-2013-S-0024-0963BioGenesis Nutraceuticals, Inc. - Dopa Factors, Pulmonary Factors - antioxidants
  180. FDA-2012-V-0588-0003FDA/CDRH Response to Edmund Char - Approval for Variance
  181. FDA-2008-P-0343-0011Acknowledgement Letter to Novo Nordisk Inc.
  182. FDA-2016-H-0250-0002Complaint
  183. FDA-2024-S-0024-13262024-002217 - Vitanergy Health Inc- Vitanergy Vitamin D3 Multivitamin Gummies with 1000IU…
  184. FDA-2020-H-0669-0001Complaint
  185. FDA-2008-N-0039-0022New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin
  186. FDA-2014-V-0629-0002Acknowledgement Letter from FDA DDM to John’s Laser Productions, dba Lasershows101
  187. FDA-2007-D-0369-2171PSG_205636 - Draft Guidance on Albuterol Sulfate
  188. FDA-2006-P-0001-0006Citizen Petition from Korein Tillery LLC
  189. FDA-2008-N-0039-0066Finding of No Significant Impact [New Animal Drugs For Use in Animal Feeds…
  190. FDA-2016-S-0024-0353NBTY Inc. - Echinacea supplements - Traditionally used for immune health
  191. FDA-2024-H-4007-0001Complaint
  192. FDA-2014-N-2244-0138Reference 130 FDA_1998_Guidance for Industry Guide to Minimize Microbial Food Safety…
  193. FDA-2023-N-3104-0001Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop; Request for…
  194. FDA-2015-N-3469-0307Nomination from Outsourcing Facilities Association
  195. FDA-2022-S-0024-11912022-001281 - TSI USA LLC - Tailored Script, Genistein - Supports women health
  196. FDA-1977-N-0002-1813Answer Letter from FDA/Division of Compliance Bureau of Veterinary Medicine to Doris G…
  197. FDA-2017-P-5787-0222CMDh Recommendation re Anxiety in Propecia SPC_EMA (Apr 2018)
  198. FDA-2015-S-0024-2135NBTY, Inc. - Osteo Bi-Flex - Joint Health
  199. FDA-2023-H-3812-0001Complaint
  200. FDA-2011-S-0932-0181Letter from NBTY, Inc.
  201. FDA-1976-N-0027-0140Answer from FDA/HF-26 to Stanford U School of Medicine
  202. FDA-2015-E-2663-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  203. FDA-2017-P-1221-0002Acknowledgement Letter from FDA DDM to Aurora Pharmaceutical LLC
  204. FDA-2017-V-4566-0003Variance Approval Letter from FDA CDRH to A-MEGA PRODUCTIONS
  205. FDA-1995-N-0054-13536Background Material for NFR 1
  206. FDA-2009-V-0498-0002Acknowledgement Letter to Platinum South Corporation, dba "DEAN'S Gold"
  207. FDA-2025-P-5560-0002Acknowledgement Letter from FDA DMB to Rubrum Advising, LLC
  208. FDA-2016-N-3120-0155redacted_105_Memo Pharmacovigilance Activity
  209. FDA-1979-P-0114-0002Acknowledgement Letter to Chase Instruments Corporation
  210. FDA-2022-E-0667-0002Patent Extension Application from Lerner, David, Littenberg, Krumholz & Mentlik, LLP (on…
  211. FDA-2016-S-0024-2298Piping Rock Health Products LLC - Potassium Gluconate Supplements - Supports normal body…
  212. FDA-2013-S-0024-0013NBTY Inc Quick Gest-RR Letter
  213. FDA-2022-D-0467-002724 Epidem Notes a Reports Poss Transfusion-Associated Acquired Imm
  214. FDA-2015-H-4571-0001CTP CMP Case re All U Need LLC d/b/a All U Need
  215. FDA-2011-N-0103-0015Reference 5 - Differential Diagnosis of Bacillus Cereus Bacillus Anthracis and Bacillus…
  216. FDA-2025-H-0051-0001Complaint
  217. FDA-2013-P-1612-0048Citizen Petition from Lee Wilson
  218. FDA-2010-P-0446-0036FDA/CDRH to University of Virginia Health System - Petition Denial
  219. FDA-2022-H-2943-0001Complaint
  220. FDA-2016-N-2470-0003FDA Pediatric Postmarketing Pharmocovigilance and Drug Utilization Review for Lysteda
  221. FDA-2017-M-5968-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  222. FDA-2015-S-0024-1121Hyalogic LLC - HA Collagen Builder a dietary supplement - For Support of Hair, Skin and…
  223. FDA-2011-S-0932-0980Atlas Therapeutics Corporation (Atlas MYO-T12 Supplements)
  224. FDA-2011-S-0932-1617Organic India, U.S.A. - Organic India Brahmi-Gotu Kola - Offers support for the nervous…
  225. FDA-2007-0629-0005Multiple Submitters [Form Letter Sample #1-Comments=501]
  226. FDA-2016-N-0001-0076Pediatric Clinical Investigator Training; Public Workshop
  227. FDA-2022-P-1668-0007Appendix 5 - Codex Alimentarius Commission, General Standard for Fruit Juices and Nectars…
  228. FDA-2016-H-0474-0002Complaint
  229. FDA-2022-H-3384-0001Complaint
  230. FDA-2012-S-1144-1538Perrigo Company of South Carolina - TopCare®-Daily Prenatal Combo Pack - Nutrient support…
  231. FDA-2018-H-0315-0001Complaint
  232. FDA-2019-S-0024-01182019002094-Viva Naturals - MULTIPLE CLAIMS (2)
  233. FDA-2024-N-5471-0193Reference 191 - Rose Adolescent tobacco coupon receipt 2018
  234. FDA-2024-N-5471-0381Reference 379 Hatsukami Effect of Immediate vs Gradual 2018
  235. FDA-2020-S-0024-13432020-001524 - Atrium-Innovations - D-Mulsion 1000 (Natural Berry Flavor) - Supports…
  236. FDA-2020-V-1020-0003Variance Approval Letter from FDA CDRH to Music By Calogero
  237. FDA-2014-N-0129-0007PBPK: Where are we now and where might we be in the future?
  238. FDA-2022-E-3123-0006Exhibit 1 - vyndamax-vyndaqel PFIZER 5-13-2022
  239. FDA-2007-P-0346-0008Reference 7 - [Richard Sauerheber, Palomar College - Citizen Petition] re…
  240. FDA-2017-N-1003-0069Request for Participation (ELP) from KARL STORZ Endovision, Inc.
  241. FDA-1990-S-0006-0200HFD-7 - Ted Sherwood
  242. FDA-2013-N-0521-0079Menthol in Cigarettes, Tobacco Products; Request for Comments; Extension of Comment Period
  243. FDA-2015-N-0001-0046Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
  244. FDA-2010-D-0378-0001Draft Compliance Policy Guides: Salmonella in Animal Feed; Availability
  245. FDA-2013-P-1511-0001PetaStrip LLC - Citizen Petition
  246. FDA-2019-H-0652-0001Complaint
  247. FDA-1995-P-0016-0189Background Material in 94P-0390
  248. FDA-2016-N-1111-0010Reference 8 - Should the FDA Ban Aversive Conditioning Devices? re Banned Devices…
  249. FDA-1993-G-0218-0157Section 2/Subsection B of Reference C-6 - Figure: Effect of Liquid Addition on the…
  250. FDA-2019-N-0721-0001Agency Information Collection Activities; Proposed Collection; Comment Request…
  251. FDA-1978-N-0018-0147Response Letter from FDA CDER to Edward Basile, King and Spalding
  252. FDA-2005-D-0086-0006uidance for Industry; Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic…
  253. FDA-2012-N-0369-0012Agency Information Collection Activities; Submission for Office of Management and Budget…
  254. FDA-1995-D-0288-001714 Reference 13 - Guidance for Review Staff and Industry Good Review Management Principles…
  255. FDA-2011-P-0032-0003Acknowledgement Letter to Anika Therapeutics, Inc. - Correction
  256. FDA-2010-S-0664-0063The Herban Alchemist - Apothe-Carry Pain-Eaze - Aids Relaxation and Supports Normal…
  257. FDA-1997-S-0039-0797NBTY, Inc. - Letter
  258. FDA-2022-E-0400-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  259. FDA-2012-S-1144-2086Doctor's Best, Inc. - Best Benfotiamine 150 + Alpha-Lipoic Acid 300 - Supports the…
  260. FDA-1975-N-0017-0068Objection from Children's Hospital Medical Center
  261. FDA-1977-N-0014-1222Answer Letter from FDA/Office of Legislative Services to Honorable Bill Chappell, House of…
  262. FDA-2020-H-1080-0001Complaint
  263. FDA-2015-D-1163-0014Revised Guidance 01 – Providing Regulatory Submissions in Electronic and Non-Electronic…
  264. FDA-1997-S-0006-1639Courtesy letter and related material from CFSAN to 3rd Day Nutraceuticals
  265. FDA-1980-N-0050-0006Bureau of Foods Research Plan (p. 1-86)
  266. FDA-2014-D-1814-0031Reference List re Bacterial Detection Testing by Blood Collection Establishments and…
  267. FDA-2017-N-1957-0052Testimony from Ann Marie Wingren
  268. FDA-2014-S-0024-1053Natural Factors Nutritional Products LTD (Celery Seed Extract) - Letter
  269. FDA-1978-N-0018-0155FDA
  270. FDA-2021-V-0688-0002Acknowledgment Letter to Lance Wallace from FDA DMS
  271. FDA-2023-P-1702-0001Citizen Petition from Center for U. S. Policy
  272. FDA-2016-N-3389-0461Exhibit E Grain Millers' Proprietary Production Process that Retains All Lignin and Other…
  273. FDA-1978-N-0018-0384FDA
  274. FDA-1989-P-0008-0027Background Material
  275. FDA-2013-D-0576-0028Reference 8 Molecular Imaging of Stem Cells Tracking Survival…
  276. FDA-2005-P-0005-0002Acknowledgment Letter from FDA DDM to ISTA Pharmaceuticals
  277. FDA-2016-H-3665-0001Complaint
  278. FDA-2023-H-2553-0001Complaint
  279. FDA-2014-N-0189-3358Request for Extension from Anonymous
  280. FDA-2016-P-2860-0001Citizen Petition from General Mills, Inc.
  281. FDA-2025-P-5713-0003Appendix A
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  283. FDA-1980-F-0030-0002Indirect Food Additivs: Adjuvants, Production Aids, and Sanitizers; Antioxidants and/or…
  284. FDA-2016-H-3175-0001Complaint
  285. FDA-1997-S-0039-0894Perrigo Company of South Carolina - Kroger®-Evening Primrose Oil - Helps support a normal…
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  302. FDA-2007-D-0369-1869PSG_020541 - Draft Guidance on Anastrozole
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  311. FDA-2025-H-5736-0001Complaint
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  313. FDA-2002-P-0169-0002HFD-600 to The Weinberg Group Inc.
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  319. FDA-1977-N-0015-0012Drugs for Human Use; Drug Efficacy Study Implementation; Potassium Aminobenzoate Oral…
  320. FDA-2025-P-3956-0031Chen, M. X., Cheng, S., Lei, L., Zhang, X. F., Liu, Q., Lin, A., Wallis, C. U., Lukowicz…
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  326. FDA-2018-N-0410-0058Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting…
  327. FDA-1997-S-0006-1695Courtesy letter and related material from CFSAN to SmartyPants Vitamins
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  329. FDA-2014-H-1362-0001Complaint
  330. FDA-2019-E-3084-0004Determination of Regulatory Review Period for Purposes of Patent Extension; TEGSEDI
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  334. FDA-1984-P-0033-0009Johnson & Johnson and McNeil Consumer Products Company Meeting with FDA - Memorandum of…
  335. FDA-2021-V-0123-0003Variance Approval Letter from FDA CDRH to Liaison Home Automation, LLC
  336. FDA-2018-N-0188-00022018_01_16 Letter from CDER to PMRS_FDA-2018-N-0188_Redacted
  337. FDA-2007-D-0369-2066PSG_216993 - Draft Guidance on Quizartinib Dihydrochloride
  338. FDA-2016-H-1822-0001Complaint
  339. FDA-2019-H-0985-0001Complaint
  340. FDA-2022-N-2390-0560Exhibit 239 - Orilissa Approval
  341. FDA-2021-N-1349-175893TAB C 2019-148 Menthol NPRM as Cleared by OMB
  342. FDA-2011-S-0933-0099Reference 6- Attachment A6 : p-Anisidine Value re NDI 695, Calanus Oil…
  343. FDA-2016-H-0700-0001CTP CMP Case re Sagar Stores Inc. d/b/a Mobil Mart
  344. FDA-2022-S-0024-03312022-000335 - Swanson Health Products 11658148874 - Swanson Health Products, Berberine…
  345. FDA-2019-H-2828-0001Complaint
  346. FDA-1999-H-0017-0002FDA/CDRH/GCF
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  349. FDA-2015-S-0023-0111NDI 895 - Xenwater from Phoenix Laboratories Inc
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  351. FDA-2019-S-0024-02702019002253 - Renew Life - RenewLife Organic Clear Prebiotic Fiber - Helps curb appetite…
  352. FDA-2023-H-3953-0001Complaint
  353. FDA-2014-N-1021-0002References Index re Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
  354. FDA-2017-D-6765-0002Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft…
  355. FDA-1980-N-0036-0039Structure of Povidone-Iodine
  356. FDA-1988-G-0298-0010Section ii Description of the Substance re GRAS Affirmation Petition for…
  357. FDA-2005-D-0272-0001FDA
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  365. FDA-2021-S-0024-13512021-001679 - BODYBIO - Calcium Magnesium Butyrate - supports a healthy inflammatory…
  366. FDA-2019-H-0950-0001Complaint
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  372. FDA-2023-H-1107-0001Complaint
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  378. FDA-2019-H-4696-0001Complaint
  379. FDA-2023-H-1410-0001Complaint
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  385. FDA-2025-H-6445-0001Complaint
  386. FDA-2019-H-0699-0001Complaint
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  390. FDA-1994-V-0006-0002Laser Products - Application for Variance
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  394. FDA-2019-H-0713-0001Complaint
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  400. FDA-2015-D-1211-0360Recommendations for Evaluating Donor Eligibility Using Individual Risk- Based Questions To…
  401. FDA-2024-H-1182-0001Complaint
  402. FDA-2024-H-1610-0001Complaint
  403. FDA-2019-S-0024-08372019-002636 - HERBALIFE INTERNATIONAL OF AMERICA, INC. - Immunity Essentials - Supports…
  404. FDA-2015-P-1674-0004Attachment C Unique Device Identification System Final Rule re Citizen Petition from…
  405. FDA-2015-N-2002-1970Reference 5 - U.S. Census - Tobacco and Tobacco Product re Clarification of When Products…
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  408. FDA-1977-N-0002-1836Answer Letter from FDA/Division of Compliance Bureau of Veterinary Medicine to Texas…
  409. FDA-2013-P-0775-0003Determination That INVEGA (Paliperidone) Extended-Release Tablet, 12 Milligrams, Was Not…
  410. FDA-2017-Q-0807-0006Reference 3- Summary Health Statistics: National Health Interview Survey re Qualified…
  411. FDA-1990-G-0246-0220Attachment A/Annex 6 - Biocatalyst for the Production of Isomaltulose Activity Assay re…
  412. FDA-2018-H-3656-0001Complaint
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  417. FDA-2017-H-0503-0001CMP Complaint from FDA CTP to Seekonk Liquors, Inc. d/b/a Chris Gasbarro’s Fine Wine and…
  418. FDA-2025-S-0024-05772025-000667 - Harmony Foods LLC. - HEB Zero Sugar Melatonin Gummies 5mg 90ct - Helps…
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  425. FDA-2004-P-0284-0001Acknowledgment Letter from FDA DMB to NuTec Incorporated
  426. FDA-2004-H-0391-0002FDA/DDM
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  429. FDA-2022-V-0985-0001Variance Application from Desert Laser Supply
  430. FDA-2020-H-0775-0001Complaint
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  435. FDA-2007-S-0484-0049NDI 391- Omega-3 Phospholipids - Original NDI Notification
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  440. FDA-2016-H-0404-0002Complaint
  441. FDA-2016-S-0023-0055NDI 915 - Vegan Lip Balm - Original NDI Notification
  442. FDA-2003-Q-0292-0042" USDA National Nutrient Database for Standard Reference " - References & Footnotes to…
  443. FDA-2016-V-1143-0003Variance Approval Letter from FDA CDRH to Mandoo Entertainment
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  447. FDA-2015-N-3469-0333Nomination from OUTSOURCING FACILITIES ASSOCIATION
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  457. FDA-2019-D-1647-0001Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for…
  458. FDA-2011-S-0933-0196HGH Pharmaceuticals (PTY) Ltd., Sceletium Tortuosum Extract (Zembrin re Section 4…
  459. FDA-1985-N-0047-0001Drugs; Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding…
  460. FDA-2004-D-0042-0006Prior Notice of Imported Food Contingency Plan for System Outages: Guidance for Industry
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  462. FDA-2025-S-0024-05962025-000686 - TSI USA LLC - Tailored Script; Acai Berry - Supports overall wellness and…
  463. FDA-2013-S-0024-0809NOW Foods - Glutathione - Free Radical Protection, Detoxification Support
  464. FDA-2009-S-0607-1239Sugarpod Organics - Go-Lacta - Increase Breast Milk Production
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  468. FDA-2023-H-4397-0001Complaint
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  473. FDA-2000-P-0102-0052Botanical Laboratories, Inc. (Kleinfeld Kaplan and Becker, LLP) - Petition for Stay
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  476. FDA-2005-N-0152-0001FDA
  477. FDA-2020-S-0024-1044SFC2020-001232 SmartyPants Vitamins - Organic Kids Formula - Supports Heart Health
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  479. FDA-1997-S-0039-1497Letter from Perrigo Company of South Carolina
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  482. FDA-2000-N-0222-0001Dietary Supplement Health Claims: Public Meeting - Notice
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  490. FDA-2013-V-1460-0001Ark Energy Production - Application for Variance
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  492. FDA-1990-N-0007-0007Reference 30 Population Strategies for Blood Cholesterol Reduction re Food Labeling…
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  495. FDA-2017-H-0953-0001CMP Complaint Issued to Dolgencorp, LLC d/b/a Dollar General Store 5733
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  499. FDA-2003-H-0215-0037HF-3
  500. FDA-2017-P-0176-0004Amendment from American Herbal Products Association
  501. FDA-2016-V-1217-0001Variance Application from DJ Mark Rambo
  502. FDA-1981-F-0005-0003Finding of no Significant Impact for FAP OH 3484, Submitted by BASF Wyandotte Corporation
  503. FDA-2017-H-6674-0001Complaint
  504. FDA-2018-H-0669-0001Complaint
  505. FDA-2016-P-3089-0006Attachment 4 ANDA Approval Letter for Cefixime chewable tablet, ANDA 065380 re Citizen…
  506. FDA-2008-D-0263-0012Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because…
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  508. FDA-2020-E-1318-0001Letter from U S Patent and Trademark Office
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  510. FDA-2016-H-3746-0001Complaint
  511. FDA-1999-N-0134-0068Risk Assessment
  512. FDA-1975-N-0248-0114Letter from Honorable Alton Lennon to FDA Re: Comment from Federal Paper Board Company…
  513. FDA-2025-P-0877-0001Suitability Petition from E. Rust Consulting, LLC
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  515. FDA-2002-N-0233-0004HF-1 to Dockets Management Branch - Memorandum
  516. FDA-2024-N-1055-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
  517. FDA-2015-S-0024-2669NBTY - Wild Yam Root supplements - Balancing herb for women
  518. FDA-2015-H-4300-0001CTP CMP Case re Walgreen Co. d/b/a Walgreens 4165
  519. FDA-2018-P-0877-0010Petition Response Letter from FDA CFSAN to The Food Lawyers
  520. FDA-2024-H-2415-0001Complaint
  521. FDA-2020-P-1549-0002Acknowledgment Letter from FDA DMS to Windels Marx Lane& Mittendorf, LLP
  522. FDA-2016-H-1028-0002Complaint
  523. FDA-2015-N-3534-0015Testimony from National Community Pharmacists Association
  524. FDA-2015-S-0024-2272NBTY, Inc. - Calcium plus Vitamin D3 - Bone density supplement
  525. FDA-2021-V-0435-0001Variance Application from Maximum Audio Video
  526. FDA-2023-P-0219-0003Attachment 1 - Endnotes 3-5_9_10-27_29_50_52 re Citizen Petition from Service Employees…
  527. FDA-2014-P-1258-0004Letter from FDA CDER to SolRx Global, Inc.
  528. FDA-2025-S-0024-07662025-000865 - Harmony Foods LLC - Equate Creatine Monohydrate Gummies 90ct - Helps support…
  529. FDA-2010-S-0664-0320Organic Liaison, LLC - Release Me - Maintains Bone Strength
  530. FDA-2009-S-0607-0399Perrigo - Target Up & Up Multivitamin - Memory Support
  531. FDA-2008-N-0027-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  532. FDA-2009-S-0607-1285Purevive Health Sciences, LLC - TigerMax - Jump-Start Libido
  533. FDA-2010-S-0664-0930North American Pharmacal, Inc. - D'Adamo Personalized Nutrition®, DetoxiCal-D - Supports…
  534. FDA-2010-N-0621-0343Dr. Midthun to Counsel, June 27, 2011 - Letter
  535. FDA-1997-S-0006-1505Courtesy Letter from CFSAN to Schwabe North America
  536. FDA-1997-S-0039-1407Horizon Nutraceuticals - Trim Science - provides a complex array of vitamins, minerals…
  537. FDA-2014-P-0916-0003Withdrawal Letter From Hope Pharmaceuticals re FDA-2014-P-0771-0003
  538. FDA-2010-S-0664-1302McLind Corporation - Lindberg CoQ10 60 mg capsules - Supports Heart Health and Cellular…
  539. FDA-2024-S-0023-0081NDI 1363 - Pasteurized Akkermansia muciniphila HB05P from Health Biome, Inc.
  540. FDA-2018-M-0528-0001P160032 approval packagePremarket Approval for Defibtech, LLC Lifeline/ReviveR DDU-100…
  541. FDA-2013-S-0024-1049Lang Paharma Nutrition - Finest Nutrition Hair, Skin & Nails Pearls - Nutritionally…
  542. FDA-2016-H-4625-0001Complaint
  543. FDA-2023-P-4321-0001Suitability Petition from Newcastle Bioscience LLC
  544. FDA-2021-P-0216-0034Letter from FDA CFSAN to EAS Consulting Group LLC 2-21-24
  545. FDA-2023-P-4587-0001Citizen Petition from Pharmobedient Consulting, LLC
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  547. FDA-2024-H-1865-0001Complaint
  548. FDA-1976-N-0518-0001Administrative Practices and Procedures; Publicity Policy - Notice of Proposed Rule
  549. FDA-2013-N-0557-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  550. FDA-2008-V-0639-0002Acknowledgement Letter to Summit Soundz
  551. FDA-2003-P-0344-0001Acknowledgment Letter from FDA DMB to Anabolic Laboratoires, Inc.
  552. FDA-2013-V-0492-0005Variance Renewal request from Laser Design Productions
  553. FDA-2023-H-4102-0001Complaint
  554. FDA-2007-P-0351-0002Acknowledgement Letter from FDA/DDM to Rothwell, Figg, Ernst & Manbeck, P.C
  555. FDA-2002-V-0139-0003Acknowledgement Letter to Lasergrace Incorporated
  556. FDA-1975-N-0012-0144Memorandum of Meeting between FDA/CDER and Soap and Detergent (SDA) and the Cosmetic…
  557. FDA-2010-S-0664-2332Perrigo - H-E-B Senior Complete - Help maintain strong bones
  558. FDA-2001-E-0149-0003U.S. Patent and Trademark Office to Glaxo Wellcome Inc.
  559. FDA-2016-P-1962-0003Interim Response Letter from FDA CDER to Hyman, Phelps & McNamara, PC
  560. FDA-2009-E-0400-0004U.S. Patent and Trademark Office to FDA/CDER - Letter
  561. FDA-2024-S-0024-00582024-000291 - Matchstick Brands LLC - Sustained energy, cognition, and recovery gummies
  562. FDA-1981-N-0015-0041Acknowledgement Letter from FDA/CDER to Colgate-Palmolive Company
  563. FDA-2023-V-3702-0002Acknowledgment Letter from FDA DMS to 3DEO
  564. FDA-2022-D-0499-0001Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen…
  565. FDA-2000-D-0075-0017Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically…
  566. FDA-2007-P-0013-0001Acknowledgement Letter to Fuerst, Humphrey, Ittleman, PL
  567. FDA-2023-N-3902-1396Comment from Anonymous
  568. FDA-2023-P-4279-0004Response Letter from FDA CDER to Pharmobedient Consulting, LLC
  569. FDA-2014-H-1033-0001Complaint
  570. FDA-1977-N-0014-1421Answer from FDA/Office of Legislative Services to Comment from United States Department of…
  571. FDA-2009-N-0484-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals
  572. FDA-2020-H-0287-0001Complaint
  573. FDA-2007-N-0259-0014Salive, Marcel
  574. FDA-1997-S-0006-1496Courtesy Letter from CFSAN to Yabao Pharmaceutical Group Co., Ltd.
  575. FDA-2004-P-0215-0015Hill Dermaceuticals, Inc., to the Division of Dockets Management - Letter
  576. FDA-2016-D-1164-0010Form FDA 3942a from Hillside Creamery
  577. FDA-2003-V-0026-0004HFZ-300 to Beaming Man
  578. FDA-2007-N-0092-0002Cardiovascular Devices: Classification of Electrocardiograph Electrodes
  579. FDA-2016-N-3120-0133redacted_081_202608_Chemistry Review
  580. FDA-2023-S-0024-00152023-000009 - Lang Pharma Nutrition- CVS Women's High Absorption Iron & Probiotics…
  581. FDA-2023-V-3614-0002Acknowledgment Letter from FDA DMS to Bradley Stockdale
  582. FDA-2008-D-0096-0033Reference-2-FDA-2015-FAC-LM-Dec-7-8-Recommendations re Control of Listeria monocytogenes…
  583. FDA-2009-F-0303-0007Environmental Assessment of Advantame (ANS9801)
  584. FDA-2011-S-0932-2427Perrigo Company of South Carolina - Multiple Claims - 8
  585. FDA-2015-P-2481-0002Acknowledgement Letter from FDA CDRH to SweetSpot Diabetes Care
  586. FDA-1996-N-0028-0461Reference 49 - "Biotics Research Products" - [Current Good Manufacturing, Packaging…
  587. FDA-2024-H-0702-0001Complaint
  588. FDA-2024-V-1762-0002Acknowledgment Letter from FDA DMS to Tech Guide, Inc
  589. FDA-2006-P-0135-0009Royal Medical Group [Sapna Lohiya] to FDA/CDER - Letter
  590. FDA-2015-D-1211-0406Reference 45_New Ref 45_Modeling the Effect of an Individual-Risk Based Deferral Policy…
  591. FDA-2024-S-0024-07182024-001547 - Gold Medal Inc - Speed Labs Energy Gum- PROMOTES ENERGY BOOST
  592. FDA-2012-S-1144-2428Vitacostcom Inc - Vitacost® Oyster Shell Calcium - Naturally sourced calcium from oyster…
  593. FDA-2025-E-3948-0002Patent Extension Application from Sleman & Lund LLP (on behalf of Abbott Cardiovascular…
  594. FDA-2011-S-0932-2806Vitacost.com, Inc. - Vitacost Trans-Resveratrol - natural antioxidant for cardiovascular…
  595. FDA-2015-D-2537-0035Presentation by Ron Fitzmartin, Ph.D., FDA/CDER regarding the Quality Metrics Public…
  596. FDA-2023-H-1266-0001Complaint
  597. FDA-2012-V-0219-0003FDA/CDRH to Event Ignition - Approval for Variance
  598. FDA-2013-P-1612-0073Citizen Petition from Julie Jackle
  599. FDA-2011-S-0932-2337Blue Sky Herbal, Inc. - Passion Formula - Support normal sex life for men
  600. FDA-1998-P-0118-0004Petition Approval Response Letter from FDA CVM to Phoenix Scientific Inc.
  601. FDA-2014-N-0189-8764Request for Extension from Heather Robb
  602. FDA-2012-P-0994-0002Acknowledgement Letter to Sheppard Mullin Richter & Hampton LLP
  603. FDA-2023-S-0024-06052023-2787 - Daiwa Health Development Inc-Daiwa Gastrolmmune™ powered by lmmunilin…
  604. FDA-2014-N-0189-33862Request for Extension from Anonymous
  605. FDA-2012-S-1144-1702NBTY, Inc. - Calcium with Vitamin D3 - Bone Health
  606. FDA-2015-H-4666-0001CTP CMP Case re Steve Stewart d/b/a Hwy 14 Quick Stop
  607. FDA-2024-V-1627-0002Acknowledgment Letter from FDA DMS to Akira Higaki
  608. FDA-2010-S-0664-0926Vitacost.com, Inc. d/b/a Nutraceutical Sciences Institute - NSI Probiotic 15-35 - For…
  609. FDA-2015-N-0101-0195Reference 7-186 - FDA-1975-N-0012-0081 -- C12 Ref - 184_Strube_Koontz 1989 re Safety and…
  610. FDA-2017-H-5022-0001Complaint
  611. FDA-2012-S-1144-1215NBTY Inc - Acidophilus - Digestive and Intestinal Health
  612. FDA-2008-P-0444-0004FDA/CDRH Interim Response to Codonics, Inc. - Letter
  613. FDA-2003-P-0123-0002Petition Approval from FDA CDER to Faulding Pharmaceutical Company
  614. FDA-2010-P-0271-0012FDA/CDER to Buchanan Ingersoll & Rooney PC - Petition Partially Denied
  615. FDA-2020-P-1052-0004Tentative Response from FDA CTP to National Tobacco Reform Initiative (NTRI)
  616. FDA-1978-N-0018-0071Letter from FDA CDER to Nonprescription Drug Manufacturers Association
  617. FDA-2016-S-0024-0880Cascara - Herbal supplement traditionally used to support healthy bowel function
  618. FDA-2007-E-0400-0001Letter from U.S. Patent Trademark Office re IONSYS (Fentanyl Iontophoretic Transdermal…
  619. FDA-2015-D-2479-0011Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry; Draft…
  620. FDA-2021-P-1346-0002Acknowledgment Letter from FDA DMS to Pet Schooled
  621. FDA-2023-S-0024-07912023-001896 - Blueroot Health - Vital Nutrients, Glycine Powder - Support for…
  622. FDA-2024-N-0008-0015Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
  623. FDA-2019-H-0936-0001Complaint
  624. FDA-2008-M-0467-0001VIABAHN Endoprothesis - Premarket Approval Application
  625. FDA-2019-H-2658-0001Complaint
  626. FDA-2012-S-1144-1225NBTY Inc - Vitamin C - Immune Health
  627. FDA-2013-N-1524-1966Nomination Letter Hydrocortisone re: Comment from Fagron
  628. FDA-2002-P-0073-0004HFC-1 to Olsson, Frank and Weeda, PC
  629. FDA-1982-N-0005-0093Tab D: Advanced Notice of Proposed Rule Making on Labeling for Salicylate-Containing Drug…
  630. FDA-2015-E-2758-0008Letter from FDA CDER to U.S. Patent and Trademark Office
  631. FDA-2002-N-0150-0004Agency Information Collection Activities; Announcement of OMB Approval; Dissemination of…
  632. FDA-2005-S-0518-0055NDI 273 - Probiotic Booster from Technology Commercialization Corp
  633. FDA-2015-V-2329-0001Variance Application from A-live Sound Experience
  634. FDA-2013-V-1045-0001Deep Symmetry, LLC - Application for Variance
  635. FDA-2022-E-2141-0002Patent Extension Application from Fish & Richardson P.C.
  636. FDA-2014-N-0189-83002Reference 94 Inhalation of Tobacco Smoke by Pipe and Cigar Smokers re Deeming Tobacco…
  637. FDA-2014-P-0748-0004Reference 1 Proposed Revised Labeling Citizen Petition from Piedmont Animal Health
  638. FDA-2011-S-0932-2953NBTY Inc - CVS-Glucosamine Complex Supplements - Joint Health
  639. FDA-2017-S-0024-07592017000917 - International Vitamin Corporation - Nature's Measure Vitamin B6 100 mg…
  640. FDA-2007-P-0002-0002Thunder Bay Seafood Co., Inc. - Petition for Stay
  641. FDA-1992-G-0167-0008Letter from FDA/HFS to Patton, Boggs and Blow re GRAS Affirmation Petition No. 2G0386…
  642. FDA-2006-P-0224-0020Reference
  643. FDA-2021-V-0503-0003Variance Approval to SeaWorld San Antonio TX from FDA CDRH
  644. FDA-2015-S-0024-2905NBTY, Inc. - L-Lysine - Skin and tissue health
  645. FDA-2006-V-0092-0002HFA-305 to William E. Komassa
  646. FDA-2017-N-2837-0001Electronic Study Data Submission; Data Standards; Support for Analysis Data Model…
  647. FDA-2018-H-4681-0001Complaint
  648. FDA-2020-D-1136-0014Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability
  649. FDA-2004-E-0266-0001U.S. Patent & Trademark Office to FDA/CDER - Letter
  650. FDA-2002-N-0029-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Aluminum…
  651. FDA-2011-N-0518-0001Notice of Filing of Petitions for Food Additives and Color Additives; Relocation in the…
  652. FDA-2017-H-4729-0001CMP Complaint Issued to Albertson’s LLC d/b/a Albertsons 940
  653. FDA-2023-H-0867-0001Complaint
  654. FDA-2021-S-0024-05692021-000890 - Nexgen Pharma- CVS High Potency Immune Support with Vitamin C, D, & Zinc…
  655. FDA-2018-N-4626-0954Nomination from Stokes Pharmacy
  656. FDA-1997-S-0039-1221Letter from Perrigo Company of South Carolina
  657. FDA-2015-S-0024-3299Perrigo - Walgreens Finest Nutrition - E - Vitamin E is an antioxidant. It works to…
  658. FDA-2015-N-0101-0746Reference 12-185 - FDA-1975-N-0012-0275 --- C80 Bibliography_ re Safety and Effectiveness…
  659. FDA-2022-D-0467-003128 Acquired immunodeficiency in an infant_possible trans blood products
  660. FDA-2015-D-3638-0001Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs…
  661. FDA-2005-D-0445-0017Reference 1 re Guidance for Industry and Food and Drug Administration Staff: Class II…
  662. FDA-1978-N-0358-0002Cranioplasty Plate Fasteners - Reference
  663. FDA-2015-N-2342-00220019_R_A0000_AMP01_CSR_16-1-10_Interlab-Standardization
  664. FDA-2020-N-1440-0001Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket…
  665. FDA-2017-S-0024-06422017000790- Nutribiotech USA- NUTRABELIEFTM 7 Day Detox- Helps Eliminate Body Waste
  666. FDA-2023-H-2373-0001Complaint
  667. FDA-1977-N-0002-1435Answer Letter from FDA to Comment from The Honorable Gary A. Myers, United States House of…
  668. FDA-2013-H-1653-0001Complaint
  669. FDA-2023-E-3238-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  670. FDA-2014-P-0585-0003Interim Response Letter from FDA CFSAN to Capstone Law APC
  671. FDA-2012-V-0858-0002Acknowledgement Letter to La Rumba
  672. FDA-2025-P-7006-0005Attachment 3
  673. FDA-1978-N-1158-0001Classification of Urethral Dilators - Notice of Proposed Rule
  674. FDA-1997-S-0006-2215Courtesy letter and related material from HFP to Vita Green Pharmaceutical (H.K.) Limited
  675. FDA-2012-S-1144-1230NBTY Inc - Vitamin C - Immune Health
  676. FDA-1998-N-0880-0006Reference 01 - Cutaneous Melanoma Attributable to Sunbed Use
  677. FDA-2014-N-0002-0023FREEDOM OF INFORMATION SUMMARY ANADA 200-468 GENTAMED-P for Poultry Injection Chickens and…
  678. FDA-1993-G-0218-0073Part K-4 : Section I - Chemical Identity for Oat Fiber and for Hydrogen Peroxide…
  679. FDA-2015-S-0024-1388BGG North America Inc - Haematococcus pluvialis microalgae - Supports healthy skin
  680. FDA-2017-N-6395-0001Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food…
  681. FDA-2014-P-2188-0014Exibit L
  682. FDA-2011-V-0538-0001Space Music - Application for Variance
  683. FDA-2018-H-3333-0001Complaint
  684. FDA-1989-G-0391-0128References: Articles and Publications (Abstracts and Authors with Letter E) re: Fifth…
  685. FDA-2003-N-0045-0043Background Information
  686. FDA-2004-E-0199-0002HFD-005 to United States Patent & Trademark Office
  687. FDA-2002-N-0033-0039Reference 11 Low-Exposure Scanning-Beam X-Ray Fluoroscopy System re Comment from…
  688. FDA-1997-S-0006-0806HFS-810 to 21st Century Laboratories Inc. - Letter - Let 495
  689. FDA-2007-N-0199-0007Norden, Janet
  690. FDA-1976-N-0476-0325Memorandum of Meeting between Showa University, Tokyo Dental College, Shell Oil Company…
  691. FDA-1997-S-0006-1214Courtesy Letter from CFSAN to Schwabe North America re Curcumax Pro
  692. FDA-2012-V-0399-0001Three Phase Productions - Application for Variance
  693. FDA-1997-S-0006-1784Courtesy letter and related material from CFSAN to CK Ingredients Inc.
  694. FDA-2014-N-0189-8785Request for Extension from Jason Higgins
  695. FDA-2023-N-4742-0026OCC Separation of Functions Memo Carbadox dated Feb 22 2024
  696. FDA-2015-N-0002-0008FREEDOM OF INFORMATION SUMMARY - NADA 141-406 NEXGARD Afoxolaner Chewable Tablet Dogs re…
  697. FDA-2016-H-0125-0002Complaint
  698. FDA-1997-S-0006-1445Courtesy Letter from CFSAN to Eclectic Institute
  699. FDA-2009-S-0607-0511Hillestad Pharmaceuticals USA, Inc. - Chia Seed - Help Maintain Regularity and…
  700. FDA-2018-H-4376-0001Complaint
  701. FDA-2012-D-1002-0002Guidance for Industry Questions and Answers Regarding Food Facility Registration Fifith…
  702. FDA-2023-V-3969-0002Acknowledgment Letter from FDA DMS to Nectar Lounge
  703. FDA-1975-N-0355-0034Acknowledgement Letter From FDA/DDM to Jame Fine Chemicals (Kleinfeld, Kaplan and Becker…
  704. FDA-1995-S-0036-0233Public Disclosure from University of Pittsburgh
  705. FDA-2021-S-0024-00732021-000077 - Atrium Innovations - Pure Encapsulations Zinc Chewables - support immune…
  706. FDA-2007-D-0369-1029PSG_215413 - Draft Guidance on Abacavir Sulfate; Dolutegravir Sodium; Lamivudine
  707. FDA-2019-H-1933-0001Complaint
  708. FDA-1975-N-0336-0034FDA/CDER to Buchanan Ingersoli & Rooney PC - Letter
  709. FDA-2015-D-4033-0007Nonprescription Sunscreen Drug Products  Format and Content of Data Submissions Guidance…
  710. FDA-2006-P-0278-0011Background Materials re: Citizen Petition from Arnall Golden Gregory LLP-Attachment 2…
  711. FDA-2018-H-0295-0001Complaint
  712. FDA-2024-D-2484-0002Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and…
  713. FDA-2019-S-0024-04912019-712 Natural Organics, Inc - MULTIPLE CLAIMS (9)
  714. FDA-2007-D-0369-1059PSG_009175 - Draft Guidance on Nitrofurantoin - Revised Guidance
  715. FDA-2016-H-0761-0001CTP CMP Case re Indie Bar II, Inc. d/b/a The Independent
  716. FDA-2025-V-0251-0003Variance Approval Letter from FDA CDRH to Avixen
  717. FDA-2018-P-1453-0013Attachment11_K - Acyclovir draft guidance re Citizen Petition from Spear Pharmaceuticals…
  718. FDA-2015-S-0024-1997Perrigo - CVS Health™ - Calcium - Helps support bone, muscle, & immune system health
  719. FDA-2023-N-3902-1560Comment from American Network of Community Options and Resources (ANCOR)
  720. FDA-2019-H-1991-0001Complaint
  721. FDA-2022-N-2390-0439Exhibit 118 - INTENTIONALLY OMITTED
  722. FDA-2024-N-5943-0021Wireframe Tobacco Ingredients Manufacturer Form 3742
  723. FDA-2013-N-0764-0014Agency Information Collection Activities; Submission for Office of Management and Budget…
  724. FDA-2018-D-1562-0005Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for…
  725. FDA-2008-D-0058-0032Testimony of Robert Buchanan, CFSAN
  726. FDA-2011-F-0172-0010Reference 11 - "FDA Reports & Research Internet Webpage: Backgrounder – Keystone Forum on…
  727. FDA-2019-H-0585-0001Complaint
  728. FDA-2018-V-2379-0002Acknowledgment Letter from FDA DDM to Rock Spring Church
  729. FDA-2013-V-0381-0002FDA/CDRH to Imax Corporation - Approval of Variance
  730. FDA-2022-H-2080-0001Complaint
  731. FDA-2011-P-0297-0005Interim Response to Public Citizen's Health Research Group - Letter
  732. FDA-2019-H-4156-0001Complaint
  733. FDA-2021-P-0424-0002Acknowledgment Letter from FDA DMS to Stryker Medical
  734. FDA-2019-S-0024-09272019-002720 - NOW Foods - Protocol For Life Balance, Ortho Thyroid - Supports thyroid and…
  735. FDA-1984-N-0259-0051Exhibit G – 4.5. re: Disclosure of Data and Information from Center for Drugs and…
  736. FDA-2025-H-5974-0001Complaint
  737. FDA-2008-D-0142-0014Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for…
  738. FDA-2007-S-0484-0123NDI 417 - Pyrroloquinoline Quinone Disodium Salt from Ullman - SUPPORTING & RELATED…
  739. FDA-2014-D-1167-0025Controlled Correspondence Related to Generic Drug Development; Guidance for Industry…
  740. FDA-2023-P-5095-0001Citizen Petition from Hyman, Phelps & McNamara, P.C.
  741. FDA-2021-P-1108-0001Citizen Petition from Xiromed, LLC (Xiromed) on behalf of Xiromed Pharma España S.L.
  742. FDA-2011-N-0002-0051Tobacco Products Scientific Advisory Committee; Notice of Meeting
  743. FDA-1986-P-0246-0003Citizen Petition from Adria Laboratories
  744. FDA-2022-D-1837-0001Statement of Identity and Strength— Content and Format of Labeling for Human…
  745. FDA-2017-P-4233-0003Attachment 1 - Approved Drug Products with Therapeutic Equivalence Evaluations, Electronic…
  746. FDA-2019-H-0318-0001Complaint
  747. FDA-2019-H-3634-0001Complaint
  748. FDA-1989-G-0391-0146References: Articles and Publications (Abstracts and Authors Lantner-Lawrence) re: Fifth…
  749. FDA-2025-H-4888-0001Complaint
  750. FDA-2010-S-0664-2717Perrigo - TopCare Garlic Tablets - Support for Cardiovascular Health
  751. FDA-2014-V-1096-0004Report on Laser Light Show or Display re Variance Application from South Carolina State…
  752. FDA-2023-V-3899-0002Acknowledgment Letter from FDA DMS to Moon Lighting Events LLC
  753. FDA-2025-H-1343-0001Complaint
  754. FDA-2024-H-1734-0001Complaint
  755. FDA-2015-H-4172-0001CTP CMP Case re Florida Family Stores Inc. d/b/a 7-Eleven 32231
  756. FDA-2007-N-0314-0029Background Material - Table of Contents to References for the Proposed Rule on Use of…
  757. FDA-2010-S-0664-2380Perrigo - Walgreens Glucosamine Chondroitin Complex - Support Healthy Joints
  758. FDA-2020-S-0024-08952020-001074 Kaged Muscle - BCAA Synergy - support hydration, fuels muscle, and recovery
  759. FDA-2006-N-0040-0078Reference 68 A Frequent Plateletpheresis Does Not Clinically Significantly Decrease…
  760. FDA-2018-E-0046-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  761. FDA-2014-V-0221-0002Acknowledgement Letter from FDA DDM to JD3 Lasers
  762. FDA-2007-E-0482-0004USPTO to FDA/CDER - Letter
  763. FDA-2009-S-0607-0985Perrigo - Vitasmart Gelatin - Bone and Joint Support
  764. FDA-2008-N-0239-0001Agency Information Collection Activities; Proposed Collection; Comment Request…
  765. FDA-1975-N-0007-0050Reference 3 - "Official Methods of Analysis of the Association of Analytical Chemists…
  766. FDA-2012-N-0002-0010New Animal Drugs: Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
  767. FDA-2018-H-0850-0001Complaint
  768. FDA-2014-V-0749-0008Appendix F - Variance Application from UTC Aerospace Systems
  769. FDA-2025-V-3957-0003Variance Approval Letter from FDA CDRH to Scott Ebersole
  770. FDA-2021-V-0696-0003Variance Approval Letter from FDA CDRH to Pao Her
  771. FDA-2010-N-0107-0020Treatment Action Group - Testimony [4/30/2010 Public Hearing]
  772. FDA-2023-H-3576-0001Complaint
  773. FDA-2016-H-0828-0001CTP CMP Case re Alpee, Inc. d/b/a Party House
  774. FDA-2003-D-0032-0001FDA
  775. FDA-2018-S-0024-05742018-3804 NAC dba New Vitality - Ageless Male Tonight - provide a rapid boost in nitric…
  776. FDA-1982-P-0018-0269Background Material
  777. FDA-2010-S-0664-2704Perrigo - CareOne Glucosamine Chondroitin Complex-MSM - Joint Health
  778. FDA-2025-V-0382-0002Acknowledgment Letter from FDA DMB to Pastel Designs LLC
  779. FDA-2021-V-0713-0001Variance Application from DJ Murph DBA Christopher Murphy
  780. FDA-2019-E-5346-0006Letter to U S Patent and Trademark Office
  781. FDA-2018-N-4626-0102Nomination from Wedgewood Pharmacy
  782. FDA-2023-H-0972-0001Complaint
  783. FDA-1991-P-0167-0002Acknowledgment Letter from FDA DDM to Calorie Control Council
  784. FDA-2018-S-0024-04912018001624-Harmony Foods - Meijer Adult Multivitamin - helps with General Health
  785. FDA-2010-E-0660-0006Regulatory Review Period for Purposes of Patent Extension: PROLIA
  786. FDA-2007-P-0191-0001Acknowledgement Letter to Lachman Consultant Services, Inc.
  787. FDA-1984-N-0259-0165Exhibit G-81 through G-92 re: Disclosure of Data and Information from Center for Drugs and…
  788. FDA-2004-P-0409-0003Citizen Petition Approval from FDA CDER to Lachman Consultant Services, Inc`
  789. FDA-2015-H-3507-0001CTP CMP Case re T and M United Corporation d/b/a BP Shop
  790. FDA-1995-S-0036-0081Report 32 - Northfield Laboratories, Inc. [BB IND 10719] - Final Public Disclosure…
  791. FDA-2020-H-1187-0001Complaint
  792. FDA-2003-V-0137-0001Laserwurx, LLC - Approval for Variance
  793. FDA-2018-H-4246-0001Complaint
  794. FDA-2005-P-0121-0011FDA to the Honorable Steven R. Rothman
  795. FDA-2023-H-5399-0001Complaint
  796. FDA-2020-P-1510-0006Appendix #10 “Over-the-Counter Drug Review,” 21 CFR part 330.1 RE: Citizen's Petition from…
  797. FDA-2025-H-7274-0001Complaint
  798. FDA-2015-S-0024-1402Perrigo Co - Good Neighbor Pharmacy® - Century Men's 50+ - Lutein, Zinc and Vitamins A, C…
  799. FDA-2023-H-5651-0001Complaint
  800. FDA-2018-D-2382-0020Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment…
  801. FDA-2017-N-6924-0006Reference 5
  802. FDA-2018-V-1603-0002Acknowledgment Letter from FDA DDM to Code Blue Sound and Entertainment
  803. FDA-2013-P-0945-0003Final Response Letter from FDA CDER to Lachman Consultant Services, Inc.
  804. FDA-2014-V-1313-0001Variance Application from Tim's National Lighting and Sound
  805. FDA-2012-S-1144-2023Waterpure, Inc. - B12 Energy Berry Melt - Supports Energy, Focus & Vitality
  806. FDA-2011-S-0932-2274International Vitamin Corporation - Vitamin C 1000 mg - Supports the immune system
  807. FDA-2019-H-5574-0001Complaint
  808. FDA-2019-S-0024-06092019-2989 Traditional Medicinals, Inc. - EveryDay Detox EveryDay Detox Schisandra Berry by…
  809. FDA-2021-N-1349-0073Reference 70 Mattingly Trends in Prevalence and Sociodemographic 2020
  810. FDA-2023-D-1027-0003Reference 1 - U.S. Department of Agriculture and U.S. Department of Health and Human…
  811. FDA-2012-S-1144-0385Indiana Botanic Choice, Inc. - Citrin - Supports weight loss
  812. FDA-1990-S-0006-0196HFD-7 - Ted Sherwood
  813. FDA-2014-N-0189-9988Request for Extension from Anonymous
  814. FDA-2004-V-0113-0002HFA-305 to Stealth DJ's Mobile Disc Jockey Service
  815. FDA-2020-P-1016-0003Appendix 2 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations…
  816. FDA-2000-N-0190-0017Renee J. Wheeler
  817. FDA-2025-S-0024-05712025-000659 - Black and Blue Foods Inc. - Pain Punch PM - Pain Punch PM - Supports a…
  818. FDA-2019-H-0528-0001Complaint
  819. FDA-2023-H-1828-0001Complaint
  820. FDA-2001-P-0241-0005Citizen Petition from Ferndale Laboratories, Inc.
  821. FDA-2004-E-0518-0003Number not used
  822. FDA-2014-P-0407-0001Citizen Petition From Almatica Pharma, Inc.
  823. FDA-2021-N-0471-0039Reference 29 FDA 2018 Guidance for Industry- Enforcement Policy
  824. FDA-2004-P-0433-0003Acknowledgment Letter from FDA DMB to GlaxoSmithKline Research & Development
  825. FDA-2025-H-5628-0001Complaint
  826. FDA-2015-V-3300-0001Variance Application from TagTeam Productions
  827. FDA-2020-H-1051-0001Complaint
  828. FDA-2013-H-1006-0001Complaint
  829. FDA-2023-E-3240-0005Letter from U.S. Patent and Trademark Office to FDA CDER
  830. FDA-2025-E-0492-0001Letter from U.S. Patent and Trademark Office to FDA CDER
  831. FDA-2024-E-1284-0007Letter to Troutman Pepper Hamilton Sanders LLP
  832. FDA-2014-E-0308-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  833. FDA-2008-N-0094-0010Attachment re Comment from CropLife America
  834. FDA-2004-P-0365-0003Citizen Petition from State of Louisiana Department of Health and Hospitals
  835. FDA-2014-N-0189-3779Request for Extension from Anonymous
  836. FDA-2020-V-1536-0003Variance Approval from FDA CDRH to Matthew Smith
  837. FDA-2015-D-0198-0004Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance…
  838. FDA-1993-N-0013-0004Transcript of the January 31, 1994 meeting
  839. FDA-2014-N-0189-83196TAB C 2014-850 Deeming RIA as Cleared by OMB
  840. FDA-2019-H-1095-0001Complaint
  841. FDA-2015-S-0024-1670Zinzino LLC - Protect - The ultimate supplement, designed to support, maintain and enhance…
  842. FDA-2011-N-0921-0393Transcript from Public Meeting FSMA Proposed Rules on Produce Safety and Preventive…
  843. FDA-2025-H-1445-0001Complaint
  844. FDA-2020-E-2269-0005Letter from FDA CDER to U S Patent and Trademark Office
  845. FDA-2025-V-1356-0002Acknowledgment Letter from FDA DMB to Christie Lites
  846. FDA-2016-N-3120-0555Letter Beers to Scheineson 5 14 19
  847. FDA-2009-D-0408-0004Reference 2 - Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria…
  848. FDA-2023-N-3902-0836Comment from Melissa Chavez
  849. FDA-2015-V-1826-0001Variance Application from VPSATL
  850. FDA-2023-H-1622-0001Complaint
  851. FDA-1997-G-0376-0026Reference 35 - Description of Erythritol - Appendix 1/15 - Stability of Erythritol In Food…
  852. FDA-2018-H-2581-0001Complaint
  853. FDA-2012-D-0049-0030Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting…
  854. FDA-2015-D-1176-0002Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry…
  855. FDA-2013-N-1484-0001Hung Yi Lin; Debarment Order
  856. FDA-2018-M-0736-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
  857. FDA-2021-V-0670-0003Variance Approval Letter from FDA CDRH to Yuri Volnov
  858. FDA-2016-N-2527-2653PRIA Reference 2 - Statistical Report - Tobacco Report Symbol, 2015
  859. FDA-2018-P-1068-0003Attachment1_A - Raney powerpoint - re Citizen Petition from Spear Pharmaceuticals, Inc
  860. FDA-2024-P-0227-0003Completeness Assessment Correspondence
  861. FDA-2007-E-0458-0023U.S. Patent and Trademark Office to Frishauf, Holtz, Goodman & Chic, P.C. - Application…
  862. FDA-1980-N-0147-0018Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal
  863. FDA-2005-P-0267-0001Acknowledgment Letter from FDA DDM to Samson Medical Technologies, LLC
  864. FDA-2015-S-0024-1235NBTY - Women's Multivitamin Gummies supplements - Supports Hair, Skin and Nail Health
  865. FDA-2020-V-2220-0003Variance Approval Letter from FDA CDRH to Arthur Dabrowski
  866. FDA-2011-N-0920-2038Reference 93-Final Rule-FDA 2012-Letter to Sunland Inc concerning Suspension of Food…
  867. FDA-2014-N-0189-5523Request for Extension from Matthew David Caples
  868. FDA-2017-H-4485-0001CMP Complaint Issued to Mike Murphy and Associates, LLC d/b/a Vaping Joes
  869. FDA-2012-S-1144-0360Now Foods - Cranberry Mannose Plus Probiotics - With Probiotics to Help Maintain a Healthy…
  870. FDA-2025-N-1927-0089GRAS Notice (GRN) 1243 with amendments, Bacillus coagulans
  871. FDA-2020-P-1601-0040Petition for Administrative Stay of Action from SIRI GLIMSTAD LLP on behalf of Informed…
  872. FDA-2016-Q-2646-0002Qualified Health Claim Petition from Burdock Group Consultants for vitamin D and reduction…
  873. FDA-2019-H-3629-0001Complaint
  874. FDA-2025-P-4985-0001Citizen Petition from Age Reversal Unity
  875. FDA-2015-N-0684-0006Attachment 2 Supplement from Allergan Inc re Comment from Allergan, Inc
  876. FDA-2022-H-1381-0001Complaint
  877. FDA-2018-H-0743-0001Complaint
  878. FDA-2015-S-0024-1174NBTY - Ginger Root supplements - For occasional nausea
  879. FDA-2016-H-0778-0001CTP CMP Case re Paxton Grocery and Meats, L.L.C. d/b/a Henke's Grocery Store
  880. FDA-2003-S-0732-0135NDI 167 - Trifolium pretense L. - Original NDI Notification
  881. FDA-2016-P-1547-0004Attachment 2 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations…
  882. FDA-2009-P-0425-0009Gail Elbek - Supplement (re FDA-2009-P-0425-0001)
  883. FDA-2008-E-0114-0011Patent Term Extension Application - Exhibit I
  884. FDA-2011-N-0504-0034Acknowledgement Letter to Neuro Fitness LLC
  885. FDA-1994-P-0041-0212BACKGROUND
  886. FDA-1997-S-0039-0777NBTY, Inc. - Letter
  887. FDA-1997-S-0006-0294See FDA-1997-S-0006-0294
  888. FDA-2025-H-2330-0001Complaint
  889. FDA-2015-S-0024-1927NBTY - Chewable Super Papaya Enzyme Plus - An advanced digestive aid, our "after-meal"…
  890. FDA-2006-D-0102-0266FDA Office of Policy & Planning to the Division of Dockets Management - Memorandum
  891. FDA-2015-H-3803-0001CTP CMP Case re Reliable Investment LLC d/b/a Sandy Acres Grocery
  892. FDA-2017-D-6294-0024Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st…
  893. FDA-2020-S-0024-03062020-000404 Arbonne International, LLC- Arbonne InnerCalm Adaptogenic De-Stress Powder…
  894. FDA-1980-N-0038-0426Certificate of Service re: Motion for Clarification or Reconsideration from FDA
  895. FDA-2024-H-0954-0001Complaint
  896. FDA-1979-N-0328-0063Supplement from Abbott Laboratories (Vol. 18 of 25)
  897. FDA-1997-S-0039-2778NOW Foods - 100% Certified Organic Acacia Fiber Pure Powder- Intestinal Health
  898. FDA-2019-H-1229-0001Complaint
  899. FDA-2016-H-4239-0001Complaint
  900. FDA-2017-N-0136-0039Attachment 1 Testimony of Lauren Emmick Hearing before The Honorable Katherine Field May…
  901. FDA-1988-P-0375-0007Withdrawal from Abbott Labs
  902. FDA-2020-E-2261-0002Patent Term Extension Application for TherOx DownStream® System Patent No 6,582,387
  903. FDA-2006-P-0089-0008Background Materials re: Citizen Petition from Custopharm, Inc- Attachment 2- Lilly…
  904. FDA-2015-N-1765-0064Reference 62 General and Plastic Surgery Devices: Restricted Sales, Distribution, and Use…
  905. FDA-2016-H-4025-0001Complaint
  906. FDA-1980-N-0038-0142Withdrawal Letter from Miles Laboratories, Inc.
  907. FDA-2015-P-4529-0011Interim Response May 19 2016
  908. FDA-2003-N-0045-0033Background Information
  909. FDA-2020-E-2224-0001Letter from U S Patent and Trademark Office
  910. FDA-2011-S-0932-2821Vitacost.com, Inc. - Vitacost Womens 50 Plus - Contains vitamin K to promote strong bones
  911. FDA-2004-P-0164-0005FDA/HFA-305 to Bill Pierson - Acknowledgement Letter
  912. FDA-1978-N-0018-0685ISO TC217 WG7 In vitro UVA Ring Test #2 Final Test Report - Report
  913. FDA-2023-V-0642-0001Variance Application from Roberto Soto
  914. FDA-2016-H-1757-0001Complaint
  915. FDA-2016-V-1240-0003Variance Approval Letter to AUGUST
  916. FDA-2017-C-1951-0237Attachment 10 RE: Termination of Listing of Color Additives Exempt From Certification…
  917. FDA-2011-S-0932-1943NBTY, Inc. - Acidophilus - Helps Maintain a Healthy Digestive System.
  918. FDA-2022-N-2390-0492Exhibit 171 - Thorpy (2012)
  919. FDA-2023-V-1070-0001Variance Application from DJ Fractalz
  920. FDA-2007-D-0369-1902PSG_022426 - Draft Guidance on Alogliptin Benzoate; Pioglitazone Hydrochloride
  921. FDA-1997-S-0006-0570HFS-456 to Advanced Care Products - Letter - Let 279
  922. FDA-2020-S-0024-06442020-000800 NOW Foods - Lucky Vitamin, Glycine - Supports nervous system.
  923. FDA-2004-P-0279-0001Acknowledgement Letter from FDA DMB to the Center for Science in the Public Interest…
  924. FDA-2024-S-0024-00462024-000237 - Sports Research - Sports Research, Collagen Peptides 8 oz - Supports Hair…
  925. FDA-2016-N-3118-0344217_FDA Study Data
  926. FDA-2019-S-0024-01222019002098-International Vitamin Corporation- Equate Magnesium 500 mg Tablets- PROMOTES…
  927. FDA-2025-H-0180-0001Complaint
  928. FDA-1975-N-0336-0105Notice of Appearance and Request for Hearing from Hoffman-La Roche, Inc.
  929. FDA-2023-H-3985-0001Complaint
  930. FDA-2013-N-1496-0006Agency Information Collection Activities; Announcement of Office of Management and Budget…
  931. FDA-1984-N-0259-0347Certificate of Service re: Center's Response to Mead Johnson's Motion Designating…
  932. FDA-1984-N-0259-0516Exhibit G-7.10 re: Disclosure of Data and Information from Center for Drugs and Biologics
  933. FDA-2025-H-1436-0001Complaint
  934. FDA-2017-H-0708-0001CTP CMP Complaint from FDA CTP to Food Lion, LLC d/b/a Food Lion 534
  935. FDA-2008-P-0348-0003Olsson Frank Weeda - Withdrawal of Petition
  936. FDA-2014-N-1051-0389388 7694105 RDC CRF Subject R2012_Redacted
  937. FDA-2004-D-0437-0002Guideline
  938. FDA-1998-P-0015-0005Bruce Friedrich (Farm Sanctuary Inc.)- Withdrawal of Citizen Petition
  939. FDA-2013-P-0946-0001Lachman Consultant Services, Inc. - Citizen Petition
  940. FDA-2025-H-1606-0001Complaint
  941. FDA-1985-P-0231-0003FDA/CDER Response to E. R. Squibb & Sons - Petition Denial
  942. FDA-2015-H-4323-0001CTP CMP Case re Ram Quick Change, Inc. d/b/a Holiday Market
  943. FDA-2010-S-0664-2524Cytosport, Inc. - Complete Whey Protein - Increase Lean Muscle Mass
  944. FDA-2016-S-0023-0126NDI 946 - Oils - Original NDI Notification
  945. FDA-2017-H-4123-0001CMP Complaint Issued to U.S. Fuel, L.L.C. d/b/a Sunoco
  946. FDA-2001-N-0201-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Food…
  947. FDA-1967-P-0018-0002Pt. 1 Exemption re: Lemonade Petitioner, Ventura Coastal Corporation 10/10/1967…
  948. FDA-2012-S-1144-0227WN Pharmaceuticals, Inc. - Webbernaturals PGX Daily - Supports weight management…
  949. FDA-2007-N-0198-0008FDA/CFSAN/ONLDS to the Division of Dockets Management, dated April 21, 2009 FDA Comments…
  950. FDA-2011-P-0646-0004Supplement from the City of Philadelphia Department of Public Health
  951. FDA-2003-N-0049-0003Background Information to NPR1
  952. FDA-2016-S-0023-0156NDI 957 - AstaPure - Original NDI Notification
  953. FDA-1997-S-0039-2879FreeLife International, Inc. - Daily Edge Advanced - Cardiovascular Health
  954. FDA-2023-V-5523-0002Acknowledgment Letter from FDA DMS to Khalil Coleman
  955. FDA-2024-H-3606-0001Complaint
  956. FDA-2020-E-1340-0006Determination of Regulatory Review Period for Purposes of Patent Extension; AXONICS SACRAL…
  957. FDA-2018-N-4626-0070Nomination from Wedgewood Pharmacy
  958. FDA-2015-H-0050-0001Complaint
  959. FDA-2011-S-0932-2010Solstice Medicine Company - Yik Mo Pills Herbal Dietary Supplement - Promotes the health…
  960. FDA-2006-P-0275-0007Citizen Petition from KV Pharmaceutical Company
  961. FDA-2023-H-0677-0001Complaint
  962. FDA-2017-E-3618-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  963. FDA-1984-G-0007-0230Background Material: E-37 Curriculum Vitae
  964. FDA-2020-S-0024-09202020-001102 Zarbees, Inc- Zarbee's Naturals Black Elderberry Immune Support- immune…
  965. FDA-2020-V-0596-0003Letter from FDA CDRH to George Jolley
  966. FDA-2019-P-4979-0002Acknowledgment Letter from FDA DMS to Andersen Pharma LLC
  967. FDA-2023-H-5664-0001Complaint
  968. FDA-2012-E-0851-0006Letter to U. S. Patent and Trademark Office
  969. FDA-2008-S-0664-0033NDI 435 - Booster Vite Liquid from Propharma, Inc.
  970. FDA-2016-V-2566-0003Variance Approval Letter from FDA CDRH
  971. FDA-2025-P-1083-0002Acknowledgment Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety…
  972. FDA-2008-P-0242-0001National Toxic Encephalopathy Foundation - Cover Ltr [FDA-2008-P-0242-0002]
  973. FDA-1994-P-0028-0047Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from…
  974. FDA-2010-S-0664-1244Waterpure, Inc. - Purity Products PS Omega-3 Formula - Promotes Memory and Mood
  975. FDA-2023-S-0024-05412023-001166 - Corporation Genacol Canada Inc. - Genacol Fast Action - Supports joint and…
  976. FDA-1986-A-0428-0003Advisory Opinion Petition Answer from FDA ORA to Chocolate Manufacturers Association
  977. FDA-2011-D-0611-0001Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation…
  978. FDA-2018-H-4473-0001Complaint
  979. FDA-2018-S-0024-02242018001390 - Jarrow Formulas, Inc. - Jarrow Formulas® Cran Clearance® - Helps Maintain a…
  980. FDA-2002-N-0031-0095The Honorable Barbara A. Mikulski to the Food and Drug Administration - Letter
  981. FDA-2015-S-0024-0269Perrigo Company of South Carolina - H-E-B® - Vitamin C - Immune Health
  982. FDA-2019-H-5415-0001Complaint
  983. FDA-2013-H-0064-0001Complaint
  984. FDA-2019-E-1145-0006Letter from FDA CDER to U.S. Patent and Trademark Office
  985. FDA-2020-D-1438-0001Redbook 2000 IV.B.1. General Guidelines for Designing and Conducting Toxicity Studies
  986. FDA-1995-N-0054-13698Background Material for NFR 1
  987. FDA-2017-N-6189-0404Nicotine Level ANPRM Track Changes Tab B of Direction to add documents to the docket in…
  988. FDA-1997-S-0006-1089[LET1089] - FDA/ONLDS/CFSAN Response to Tahitian Noni International - Courtesy Letter
  989. FDA-2007-D-0369-1531PSG_021911 - Draft Guidance on Rufinamide
  990. FDA-2020-S-0024-12842020-001476 - Glanbia Performance Nutrition - Optimum Nutrition ON Gummies - Opti-Men +…
  991. FDA-1998-F-0031-0001Withdrawal of Food Additive Petitions Subsequently Converted to Food Contact Notifications
  992. FDA-2002-P-0291-0003FDA/CDER to Teva Pharmaceuticals USA, Inc.
  993. FDA-2003-N-0446-0024FDA
  994. FDA-2024-H-5604-0001Complaint
  995. FDA-2022-V-1688-0002Acknowledgment Letter from FDA DMS to Traveling Performers
  996. FDA-2024-S-0024-09342024-001806 - Nordic Naturals - Nordic Naturals Memory Support Omega Blend- promotes…
  997. FDA-2015-S-0024-1058Perrigo Co - Smart Sense®- Century Men - B-vitamins and Iron facilitate cellular energy…
  998. FDA-2014-N-1051-0399398 7694105 RDC CRF Subject R2022_Redacted
  999. FDA-1997-S-0006-1670Courtesy letter and related material from CFSAN to WuHan JianMinDaPeng Pharmaceutical…
  1000. FDA-2023-H-0755-0001Complaint

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