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Regulations.gov documents

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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2009-N-0383-0004.

  1. FDA-2014-N-0189-10004Request for Extension from Anonymous
  2. FDA-2019-H-1631-0001Complaint
  3. FDA-2024-N-5471-0288Reference 286 Substance Abuse Key substance use and mental 2020
  4. FDA-1978-N-0022-0022Letter from FDA/CDER to Otis Clapp
  5. FDA-2009-S-0607-0931Perrigo - Equaline Century Mature - Immune Support
  6. FDA-2015-H-4097-0001CTP CMP Case re JHJ Marathon, Inc. d/b/a Marathon
  7. FDA-2015-S-0024-2713Country Life - Life/Papaya Digestive Support - Natural digestive enzyme support
  8. FDA-1989-M-0012-0003HEADOX MEDICALS, INC.; PREMARKET APPROVAL OF STRYKER* DACRON* LIGAMENT PROSTHESIS
  9. FDA-2008-N-0567-0112013 Reference 12 - Measuring the Burden of Arboviral Diseases The Spectrum of Morbidity…
  10. FDA-2015-V-0365-0003Variance Approval from FDA CDRH to DANNY STAGE, LIGHT AND SOUND
  11. FDA-2014-N-0189-8602Request for Extension from Anonymous
  12. FDA-2017-V-5735-0004Variance Approval from FDA CDRH to ANDREW WENSEL
  13. FDA-2010-S-0664-1518Letter from Perrigo Company of South Carolina
  14. FDA-2016-H-4622-0001Complaint
  15. FDA-2025-H-2651-0001Complaint
  16. FDA-2016-N-2527-0269Request to Extend Comment Period from Reason Foundation
  17. FDA-2019-N-3065-0129Reference 127 - Impact of Tobacco-Related Health Warning Labels Across Socioeconomic, Race…
  18. FDA-2007-D-0369-1440PSG_021073 - Draft Guidance on Pioglitazone Hydrochloride
  19. FDA-2018-H-0431-0001Complaint
  20. FDA-2006-P-0448-0005Acknowledgment Letter from FDA DMB to Pfizer Inc.
  21. FDA-2022-V-2885-0002Acknowledgment Letter from FDA DMS to Kratos Production
  22. FDA-2007-D-0369-1395PSG_020764 - Draft Guidance on Lamotrigine
  23. FDA-2016-H-1560-0001Complaint
  24. FDA-1997-S-0039-2156Perrigo Company of South Carolina - Kroger® - One Daily - This product is formulated…
  25. FDA-2014-N-0189-83033Reference 125 Flavoring Chemicals in E-Cigarettes Diacetyl re Deeming Tobacco Products To…
  26. FDA-2010-P-0533-0001Zydus Pharmaceuticals USA, Inc. - Citizen Petition
  27. FDA-2006-P-0400-0002Acknowledgment Letter from FDA DMB to Beckloff Associates, Inc.
  28. FDA-1983-P-0011-0002HFA-305 to Phillippe Douillet
  29. FDA-2006-P-0328-0003Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.
  30. FDA-2011-V-0870-0001MSA Lighting & Sound LLC - Application for Variance
  31. FDA-2019-S-0024-02162019002198- SP Nutraceuticals Inc - Avocado Powder- Support the body's use of sugar…
  32. FDA-2009-D-0283-0021Guidance for Industry Postmarketing Stuides and Clinical Trials - Implementation of…
  33. FDA-2014-H-0969-0001Complaint
  34. FDA-1984-N-0259-0435Order for Mead Johnson to Provide Redacted Copy of Transcript
  35. FDA-1978-N-0018-0173FDA
  36. FDA-2023-E-3109-0002Patent Extension Application from Ballard Spahr LLP on behalf of Revance Therapeutics Inc.
  37. FDA-2021-V-0251-0003Variance Approval Letter from FDA CDRH to Adam Bourassa
  38. FDA-2023-P-5675-0004Attachment 2 Draft Package Insert Proposed for posaconazole
  39. FDA-2017-H-6041-0001Complaint
  40. FDA-2011-P-0610-0005AbbVie Inc. (Hogan Lovells) - Supplement
  41. FDA-1981-N-0293-0020American Academy of Pediatrics - Appearance Request (2)
  42. FDA-2016-H-4014-0001Complaint
  43. FDA-1998-E-0012-0001Determination of Regulatory Review Period for Purposes of Patent Extension; Synvisc Hylan…
  44. FDA-2019-S-0024-04602019002453-International Vitamin Corporation - MULTIPLE CLAIMS (2)
  45. FDA-2009-P-0282-0001Pepper Hamilton, LLP - Citizen Petition
  46. FDA-1990-G-0246-0021Section 1/Annex 1/Literature Number 4 - Letter from Federal [GERMAN] Minister for…
  47. FDA-2020-V-1779-0002Acknowledgment Letter from FDA DMS to David Williams
  48. FDA-2023-S-0024-03462023-000526 - Jarrow Formulas - Jarrow Formulas, Evening Primrose - Support for mild PMS…
  49. FDA-1997-S-0006-0984HFS-810 to Pharmaton Natural Health Products Division of Boehringer Ingelheim…
  50. FDA-2018-H-0977-0001Complaint
  51. FDA-2023-P-4550-0002Acknowledgment Letter from FDA DMS to Pharmobedient Consulting, LLC
  52. FDA-2018-H-0150-0001Complaint
  53. FDA-2016-P-2559-0024Exhibit 20 Response to Manufacturers submissions from Kendrick Moxon re Citizen Petition…
  54. FDA-1984-N-0259-0318Certificate of Service re: Reply to Motion from Mead Johnson and Company to FDA
  55. FDA-2019-N-3065-0044Reference 42 - Preventing Tobacco Use among Youth and Young Adults_A Report of the Surgeon…
  56. FDA-2008-P-0175-0002Acknowledgement Letter to Beckloff Associates, Inc.
  57. FDA-2014-N-1051-0301300 7694105 Diary Subject R5021_Redacted
  58. FDA-2017-H-4693-0001CMP Complaint Issued to Guddi’s Corner, LLC d/b/a Carrier Party Store
  59. FDA-1980-N-0038-0042Request for Hearing from Pfizer, Inc.
  60. FDA-2020-V-1615-0001Variance Application from Tyler Hoag
  61. FDA-2016-H-1001-0001CTP CMP Case re Rally Mart Inc. d/b/a Rally Mart 1 / Exxon
  62. FDA-2012-S-1144-0409McLind Corporation - Organic Greens & Fruits Plus - Help you achieve the 5+ recommended…
  63. FDA-2020-S-0024-0545SFC2020-000676 Bio Extracts- Baraka, Memo+ Advanced- Promotes improve mind memory loss…
  64. FDA-1997-A-0538-0002Acknowledgment Letter from FDA DDM to R.F. Nestler & Associates, Inc.
  65. FDA-2021-N-0862-0201TAB A-2017-723-NSURE-PRIA RE Memorandum - Nonprescription Drug Product With an Additional…
  66. FDA-2020-V-1610-0002Acknowledgment Letter from FDA DMS to Nathan Taylor
  67. FDA-2016-H-2077-0001Complaint
  68. FDA-2011-F-0172-2280Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail…
  69. FDA-2025-S-0024-09432025-001022 - Labonix Corp - PureWell UNWIND - CALMS DOWN NERVOUS SYSTEM WITHOUT DIRECT…
  70. FDA-2015-H-4222-0001CTP CMP Case re Arya Green Markets, Inc. d/b/a Fishermen’s Green Market and Deli
  71. FDA-2018-S-0023-0009NDI 1054 - Agave salmiana sap concentrate - Reference List
  72. FDA-2010-S-0664-0045Nexgen Pharma, Inc. - Omega-3 Once Daily - Supports Cardiovascular and Brain Health
  73. FDA-2009-Q-0301-0013Cover Letter from Nestle Nutrition to FDA/CFSAN - Cover Letter for Redacted Supporting…
  74. FDA-2024-H-3831-0001Complaint
  75. FDA-2021-V-0675-0001Variance Application from Benjamin Kowalkowski
  76. FDA-2025-S-0024-04922025-000577 - SmartyPants Vitamins - Women's Plus 50+ Multi & Omegas - promotes Bone…
  77. FDA-2015-H-0210-0001Complaint
  78. FDA-2023-H-0419-0001Complaint
  79. FDA-2004-N-0048-0006Supporting Statement for Medical Devices Current Good Manufacturing Practice (CGMP)…
  80. FDA-2014-N-0189-5369Request for Extension from Anonymous
  81. FDA-2004-N-0059-0019Scientific Workshop 02/14/05-Breakout Session D-Clinical Pharmacology Studies
  82. FDA-2000-P-0097-0003Memorandum from Regulations & Policy Management Staff to Division of Dockets Management…
  83. FDA-1990-G-0398-0010Consumption (ii)(e) re: GRAS Affirmation Petition from The NutraSweet Company
  84. FDA-2016-D-1210-0031Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry…
  85. FDA-2016-P-3428-0001Suitability Petition from Douglass Oeller Consulting, Inc (Felix Pharmaceuticals Pvt. Ltd)
  86. FDA-2023-H-0774-0001Complaint
  87. FDA-1992-G-0275-0053Section 1/Reference 33 - Food Research In Provendor-An Example re Sugar Beet Fiber from…
  88. FDA-2015-N-0101-1076Reference 168 - Havler & Rance, Metabolism of PCMX in Sprague Dawley and Gunn Wistar Rats…
  89. FDA-2019-S-0024-02552019002237 - Careof - Creatine - Supports muscle development
  90. FDA-2024-H-1261-0001Complaint
  91. FDA-2020-D-0987-0001Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity…
  92. FDA-2014-D-0055-0564Reference 1 - Food and Drug Administration, “Voluntary Sodium Reduction Goals: Target Mean…
  93. FDA-2025-V-0561-0003Variance Approval Letter from FDA CDRH to Michael Nichols
  94. FDA-1992-N-0190-0015Extension of Comment Period from FDA/CFSAN
  95. FDA-2016-H-0605-0002Complaint
  96. FDA-2009-V-0562-0003FDA/CDRH Response to Staged Right Productions - Approval for Variance
  97. FDA-2012-S-1144-1873PuraPharm International (H.K ) Ltd. - Multiple Claims - 50
  98. FDA-2022-V-2376-0002Acknowledgment Letter from FDA DMS to Tyler Eshkenazi
  99. FDA-2023-D-4974-0001Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry…
  100. FDA-2021-D-1149-0001Transition Plan for Medical Devices Issued Emergency Use Authorizations During the…
  101. FDA-2024-S-0024-03722024-001121 - Fulgent Life Inc - SOBER RUSH & FLYNEW, ALCOHOL DETOX ENZYME - HELPS LIVER…
  102. FDA-2025-P-1085-0001Suitability Petition from Xiromed, LLC.
  103. FDA-2021-S-0024-05402021-000762 - NOW Foods - NOW Foods, PQQ Energy - Supports mitochondrial function
  104. FDA-2017-H-0125-0001Complaint from FDA CTP to MSM Grocery and Deli, Inc., d/b/a MSM Grocery II and Deli
  105. FDA-2008-N-0356-0001Global Harmonization Task Force, Study Groups 1 and 3; Proposed and Final Documents…
  106. FDA-2017-H-4768-0001CMP Complaint Issued to South Lake Serene LLC d/b/a Lake Serene Grocery
  107. FDA-2004-V-0227-0001HFA-305 to It's A Party Entertainment
  108. FDA-2025-H-2315-0001Complaint
  109. FDA-2020-V-2220-0002Acknowledgment Letter from FDA DMS to Arthur Dabrowski
  110. FDA-2018-H-4875-0001Complaint
  111. FDA-2006-V-0096-0006FDA/CDRH Response to Universal Studios Florida - Approval for Variance
  112. FDA-2024-N-2910-0101Memo to FDA DMB re Food Labeling: Front-of-Package Nutrition Information (proposed rule)
  113. FDA-2015-V-3017-0002Acknowledgement Letter from FDA DDM to Prox Live Performance Gear
  114. FDA-1996-N-0006-0047Letter from Morgan, Lewis & Bockius, LLP to FDA/CDER Questions
  115. FDA-2008-N-0549-0049Attachment 2 Declaration of Brian Guy re Petition from Buchanan Ingersoll & Rooney PC on…
  116. FDA-2016-N-3118-0374254_FAERS
  117. FDA-2023-V-0034-0001Variance Application from Greg Sutherland
  118. FDA-2002-E-0161-0001HFD-005 to U.S. Patent and Trademark Office
  119. FDA-2022-N-1128-0011Reference 10- Monetizing Bowser: A Contingent Valuation of the Statistical Value of Dog…
  120. FDA-2014-V-0414-0001Variance Application from DJCain.com
  121. FDA-2025-P-0436-0011Appendix I
  122. FDA-1995-G-0184-0003Letter to FDA Gist-brocades International B.V re Petition requesting GRAS affirmation of…
  123. FDA-2004-N-0508-0007Transcript of 11/16/2004 Public Meeting
  124. FDA-2023-H-1199-0001Complaint
  125. FDA-2023-H-0072-0001Complaint
  126. FDA-1987-N-0054-0025Exhibit G-99 - G-99.1; G-100 - G-111; G-112; G-114; G-122 – G-125.3; G-125.7 G-125.9…
  127. FDA-2023-H-1788-0001Complaint
  128. FDA-2025-H-4720-0001Complaint
  129. FDA-2010-M-0135-0001Boston Scientific Corporation - Premarket Approval Package
  130. FDA-2000-D-0187-0042Ref 14 FDA Blood Products Advisory Committee - Sept 2008 Re: Revised Recommendations to…
  131. FDA-2017-E-4282-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  132. FDA-1986-D-0038-0008FDA
  133. FDA-2025-V-1035-0003Variance Approval Letter from FDA CDRH to Embers of Floyd LLC
  134. FDA-2014-N-1051-0367366 7694105 RDC CRF Subject R1027_Redacted
  135. FDA-2002-N-0233-0197See FDA-2002-N-0233-0217
  136. FDA-2023-H-1497-0001Complaint
  137. FDA-1994-P-0054-0024Acknowledgement Letter to Robert Cohen
  138. FDA-2018-M-4777-0001Premarket Approval Response from FDA CDRH to Medtronic, Inc.
  139. FDA-2011-N-0921-18648Reference 89_FDA_2008_Fresh-Cut Fruit and Vegetable Guide re Standards for the Growing…
  140. FDA-1980-N-0038-0240Memorandum from Thomas Scarlett FDA to Staff Attorneys
  141. FDA-2000-S-1575-0001NDI 56 - Respivax from Biocare medical Technology, LLC on behalf of N/A/T/O International
  142. FDA-1997-P-0357-0004Approval Response Letter from FDA CDER to Gensia Labs, LTD.
  143. FDA-2007-P-0286-0002FDA/CFSAN and Dr. Wulf Droge
  144. FDA-2003-P-0005-0009Attachment 8 - Letter from Donald A. Gable, Fermenta Animal Health, to Center for…
  145. FDA-2025-H-4393-0001Complaint
  146. FDA-2016-H-2953-0001Complaint
  147. FDA-2004-D-0042-0003Guidance for Industry Prior Notice of Imported Food Contingency Plan for System Outages
  148. FDA-2018-H-1886-0001Complaint
  149. FDA-2007-E-0399-0009Patent Term Extension Application - Exhibit 5
  150. FDA-2021-S-0024-09302021-001247 - Swanson Health Products 11658148874 - Swanson Health Products, Collagen…
  151. FDA-2017-V-4092-0002Acknowledgement Letter from FDA DDM to Big Time Operators, Inc.
  152. FDA-2023-S-0024-05172023-001057 - Thrive Market Inc. - MULTIPLE CLAIMS (11)
  153. FDA-1990-N-0005-0010Reference 16
  154. FDA-2019-E-3295-0006Determination of Regulatory Review Period for Purposes of Patent Extension; GALAFOLD
  155. FDA-2012-S-1144-0076Revo Global, Inc. (Thermo-GTE Complex, Cal-D-K Essentials, ReV-Beauty, HSN Essentials…
  156. FDA-1996-P-0383-0004Acknowledgement Letter to Fuisz Technologies LTD
  157. FDA-2011-P-0186-0002Attachment 1- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations…
  158. FDA-2022-E-2035-0003Letter to U S Patent and Trademark Office from FDA CDER
  159. FDA-2010-S-0664-191321st Century HealthCare, Inc. - Natural C-500 with Rose Hips Tablets - Neutralize Free…
  160. FDA-2014-V-0769-0002Acknowledgement Letter from FDA DDM to Off The Chart Entertainment
  161. FDA-1990-G-0398-0003Proposed Amendment to 21 CFR 184.1498 re: GRAS Affirmation Petition from The NutraSweet…
  162. FDA-2024-H-2269-0001Complaint
  163. FDA-2018-S-0024-00322018-892 Water Pure dba Purity Products - Optimized Fish Oil+ Vitamins C&D - Support for…
  164. FDA-2013-H-1068-0001Complaint
  165. FDA-2021-N-1309-0440PRIA Reference 128 CBO Long Term Budget Outlook 2021
  166. FDA-1994-G-0059-0001Letter from FDA CFSAN to M.G. Waldbaum Co
  167. FDA-1987-N-0010-0097Background Material
  168. FDA-2006-Q-0509-0003Kraft Foods Global Inc - Appendix-B - Analytical Methodology
  169. FDA-2021-S-0024-02332021-000271 Beijing Kingbird Pharmaceutical Technology Development Co.Ltd - Garlic Oil…
  170. FDA-2014-N-0189-6728Request for Extension from Anonymous
  171. FDA-2017-P-5124-0004Final Response Letter from FDA to Hyman, Phelps & McNamara, PC
  172. FDA-1994-N-0052-0001Mohammad Uddin; Debarment Order
  173. FDA-2015-D-5073-0030Reference 4 - Centers for Disease Control and Prevention. Surveillance for Viral…
  174. FDA-2014-N-0189-7802Request for Extension from Anonymous
  175. FDA-2019-H-4148-0001Complaint
  176. FDA-2008-N-0567-0133034 Reference 33 - Rabies Surveillance in the United States During 2014
  177. FDA-2003-P-0119-0001Petition Approval from FDA CDER to Lachman Consultant Services, Inc.
  178. FDA-2011-S-0932-1797NBTY, Inc. - Vitamin D Dietary Supplements - For Bone Health
  179. FDA-2017-E-6372-0002Letter from U.S. Patent and Trademark Office to CDER
  180. FDA-2024-N-1181-0001Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New…
  181. FDA-1998-N-0026-0002FDA
  182. FDA-2019-H-5233-0001Complaint
  183. FDA-2020-P-0863-0281Reference 266 Lu et al., 2013 re: Qualified Health Claim Petition from Sevo…
  184. FDA-2024-V-5682-0001Variance Application from Fulsi FX
  185. FDA-2024-H-2116-0001Complaint
  186. FDA-2019-N-0983-0001Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public…
  187. FDA-2018-V-0248-0001Variance Application from The Ocotillo Group Productions
  188. FDA-2021-P-0582-0005Attachment 3 RE Petition for Reconsideration from IONTOX, LLC
  189. FDA-2023-H-1158-0001Complaint
  190. FDA-1976-N-0476-0049Statement from Dr. Clifford F. Thompson re: Good Laboratory Practices for Nonclinical…
  191. FDA-2013-D-0715-0132Reference 113 Addressing the Challenge of Acrylamide in the Bakery Sector re Acrylamide in…
  192. FDA-2017-H-0683-0001CMP Complaint from FDA CTP to Wal-Mart Stores East, LP d/b/a Wal-Mart 3713
  193. FDA-2022-S-0024-01982022-000181 - Coral Group Inc.- Coral Group A Herbal Dietary Supplement- Supports the…
  194. FDA-2012-S-1144-1954Vitacost.com, Inc. - Vitacost Eye Defense Formula - Daily, multi-nutrient formula provides…
  195. FDA-2022-V-2603-0003Variance Approval Letter from FDA CDRH to Don's Service Connection
  196. FDA-2019-E-3063-0004Requirement for Information Letter
  197. FDA-2023-H-3934-0001Complaint
  198. FDA-1977-N-0002-1135Answer Letter from FDA/Office of Legislative Services to Honorable Marjorie S. Holt, House…
  199. FDA-2009-E-0240-0006Letter from U.S. Patent and Trademark Office to Knobble Martens Olson & Bear LLP
  200. FDA-2004-N-0059-0047References for Citizen Petition Response
  201. FDA-2020-D-0957-005554-Reviewer-Guidance-for-Nebulizers--Metered-Dose-Inhalers--Spacers-and-Actuators
  202. FDA-2021-V-0841-0003Variance Approval to Thomas Blahnik from FDA CDRH
  203. FDA-2015-Q-4850-002290 day extension letter to from FDA to Johnson Nutrition Solutions LLC
  204. FDA-2011-N-0899-0001Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning…
  205. FDA-2015-Q-2352-0001Health Claim Petition from EAS Consulting Group, LLC
  206. FDA-2014-S-0024-0961Natural Factors Nutritional Products LTD (Liquid Kelp) - Letter
  207. FDA-2013-D-1067-0004Patient Counseling Information Section of Labeling for Human Prescription Drug and…
  208. FDA-2025-H-7162-0001Complaint
  209. FDA-2010-P-0444-0002Acknowledgement Letter to the Mayo Clinic - Correction
  210. FDA-2022-S-0024-11132022-001159 - Factors Group of Nutritional Companies Inc- Natural Factors, Total Body…
  211. FDA-2012-P-1252-0007Reference 1 - Final Study Report - Non-Clinical Laboratory Study: The Effects of Paylean®…
  212. FDA-1999-N-0113-0099Background Information
  213. FDA-2009-D-0430-0086Exhibits 100 and 101 Mintel Database Prododuct Label Images 4000+ Boxes 1 and 2 Exhbs 300…
  214. FDA-2014-D-1814-0029Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion…
  215. FDA-2022-P-0704-0006Response Letter from FDA CBER to San Rocco Therapeutics
  216. FDA-2002-N-0323-0112New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules
  217. FDA-2007-P-0114-0002Acknowledgement Letter from FDA DDM to B Braun Medical, Inc.
  218. FDA-2009-N-0360-0004Agency Information Collection Activities; Proposed Collection; Comment Request; Food and…
  219. FDA-1997-S-0006-1304Courtesy Letter from CFSAN to Regulatory Affairs Associates
  220. FDA-1995-P-0324-0017Exhibit 1 Description of Milk Types re: Citizen Petition from American Dairy Products…
  221. FDA-2022-E-2141-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  222. FDA-2022-H-1829-0001Complaint
  223. FDA-2017-D-0829-0005Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance…
  224. FDA-1977-N-0025-0229Appendix A re: Comment from McNeil Consumer & Specialty Pharmaceuticals
  225. FDA-2019-H-3007-0001Complaint
  226. FDA-1993-M-0005-0003Ventritex, Inc. - Approval of Application
  227. FDA-2022-H-1484-0001Complaint
  228. FDA-2007-D-0369-1740PSG_212904 - Draft Guidance on Tivozanib Hydrochloride
  229. FDA-2016-H-0430-0002Complaint
  230. FDA-2024-H-5359-0001Complaint
  231. FDA-2021-V-0799-0001Variance Application from Alexander Ryzinski
  232. FDA-1978-N-0018-0567Envelope re: Comment from Elmont T. Gray
  233. FDA-2016-H-2188-0001Complaint
  234. FDA-2021-P-1111-0001Citizen Petition from Lachman Consultant Services Inc
  235. FDA-2023-E-2611-0005Letter from FDA CDER to U. S. Patent and Trademark Office
  236. FDA-2004-D-0121-0001FDA
  237. FDA-2020-P-1871-0001Citizen Petition from Siri & Glimstad LLP on behalf of Informed Consent Action Network
  238. FDA-2007-D-0369-1450PSG_021086 - Draft Guidance on Olanzapine
  239. FDA-2014-S-0024-0366Perrigo Company (Health Mart - Complete) - Letter
  240. FDA-1984-N-0259-0511Exhibit G-7.5 re: Disclosure of Data and Information from Center for Drugs and Biologics
  241. FDA-2013-N-1428-0019Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under…
  242. FDA-2025-V-2029-0003Variance Approval Letter from FDA CDRH to Alex Lee
  243. FDA-2014-V-2005-0001Variance Application from Scottsdale Public Arts
  244. FDA-1984-N-0403-0001Lemmon Co.; New Drug Applications; Withdrawal of Approval
  245. FDA-2024-E-0428-0005Letter to U.S. Patent and Trademark Office
  246. FDA-2010-S-0665-0103NDI 646, Aureo beta Glucan from Aureo Company, LTD
  247. FDA-2014-H-1215-0001Complaint
  248. FDA-2021-V-0795-0003Variance Approval Letter from FDA CDRH to Kurt Vestil
  249. FDA-2007-D-0369-2348PSG_020664 - Draft Guidance on Cabergoline
  250. FDA-2024-V-2911-0004Variance Renewal Application from Milne Pocock
  251. FDA-2022-H-1058-0001Complaint
  252. FDA-2006-P-0442-0002Acknowledgment Letter from FDA DMB to West-Ward Pharmaceutical, Corp.
  253. FDA-2024-D-5601-0016E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft…
  254. FDA-2013-N-1524-1984Nomination Letter Isopropyl Palmitate re: Comment from Fagro
  255. FDA-2012-S-1144-1520Waterpure, Inc., d.b.a Purity Products - AstaOmega - Supports strength and endurance
  256. FDA-2013-N-1524-1994Nomination Letter Ketorolac Tromethamine USP re: Comment from Fagron
  257. FDA-1984-C-0171-0002Finding of No Significant Impact re: CAP 4C0181 Davis & Geck - American Cyanamid
  258. FDA-2016-S-0024-1674Perrigo Co - CareOne® - Biotin, Target up & up® - biotin - Biotin plays a role in hair and…
  259. FDA-2014-N-0053-0167FDA Tab B - Tracing PRIA - OMB redline changes 7-20-20 to 9-5-20 RE Requirements for…
  260. FDA-1990-G-0398-0006Federal Register Notice 53FR47580 Docket 88G-0371; The NutraSweet Co.; Filing of Petition…
  261. FDA-2020-H-0759-0001Complaint
  262. FDA-2023-H-1602-0001Complaint
  263. FDA-2017-S-0024-09052017001076 - FoodState - (INNATE) Thyroid Response Complete Care - Sensoril Ashwagandha…
  264. FDA-2019-H-0518-0001Complaint
  265. FDA-2006-N-0040-0085Reference 75 Safety Reporting Requirements for Human Drug and Biological Products Proposed…
  266. FDA-2005-D-0211-0025Reference
  267. FDA-2021-N-0363-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
  268. FDA-2002-P-0247-0020Mission Possible International Multiple Signatures 461 Supplement Citizen Petition SUP 4
  269. FDA-1999-N-0113-0165FDA
  270. FDA-2020-S-0024-02302020-000317 Schwabe North America - MULTIPLE CLAIMS (5)
  271. FDA-2019-H-2644-0001Complaint
  272. FDA-2005-P-0319-0022Final Response
  273. FDA-1997-S-0039-1191Letter from Genuine Health Corporation
  274. FDA-2020-E-2362-0003Patent Term Extension Letter from FDA CDER to Honorable Drew Hirshfeld
  275. FDA-2014-N-0189-4821Request for Extension from Marc
  276. FDA-2013-N-1119-0012Agency Information Collection Activities; Announcement of Office of Management and Budget…
  277. FDA-2014-N-0297-0060Reference 1,Ob Gyn Panel Meeting Transcript. Sept 8 2011 re Obstetrical and Gynecological…
  278. FDA-1984-P-0033-0022Johnson & Johnson to FDA Dockets Management Branch - Letter
  279. FDA-2023-N-3902-0326Comment from Anonymous
  280. FDA-2016-P-2737-0030Attachment 27 - Appendix Tab 79-14-1 re Citizen Petition from Natural Resources Defense…
  281. FDA-2023-N-3902-0838Comment from Danielle Gregoire
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  508. FDA-2024-S-0024-05212024-001336 - Lang Pharma Nutrition - HEB Melatonin-Free Deep Sleep Support- PROMOTES…
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  544. FDA-2012-S-1144-2679Perrigo - Meijer® - Promotional - keeping up with your bone & joint health
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  834. FDA-2025-E-3622-0001Letter from U. S. Patent and Trademark Office
  835. FDA-2024-H-3807-0001Complaint
  836. FDA-1997-S-0039-2368Perrigo Company of South Carolina - Good Health- Calcium, Magnesium and Zinc - Strong…
  837. FDA-2018-D-2456-0011Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results…
  838. FDA-2024-H-0406-0001Complaint
  839. FDA-2016-V-1263-0001Variance Application from Balloonheads Pro Audio & Lighting
  840. FDA-2023-V-2750-0003Variance Approval Letter from FDA CDRH to Kate Swan, LLC
  841. FDA-2025-H-0542-0001Complaint
  842. FDA-2024-E-0194-0003Letter from FDA CDER to U.S. Patent and Trademark Office
  843. FDA-1994-P-0041-0100BACKGROUND
  844. FDA-2009-Q-0301-0024Consultation Between CDER DPARP and CFSAN on "Most Common Disease....", March 15, 2011…
  845. FDA-2015-N-0101-0013Reference 7-4 - FDA-1975-N-0012-0081 -- C12 Ref - 2 _Ahmed_Abbas 1993 re Safety and…
  846. FDA-2000-N-0163-0012"Index of Supporting Documents" - [Biological Products; Bacterial Vaccines and Related…
  847. FDA-2008-P-0621-0003Exhibit 1 - U.S. Patent No. 5,164,405 - McFarlane et al [EKR Therapeutics, Inc. - Citizen…
  848. FDA-2010-S-0665-0015NDI 642, AvoCetyl from Cyvex Nutrition
  849. FDA-2009-P-0362-0011Ryszard Rokicki - Supplement Citizen Petition
  850. FDA-2003-V-0356-0002HFA-305 to Warner Bros. Entertainment Inc.
  851. FDA-2017-E-6744-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
  852. FDA-2025-S-0024-06242025-000716 - Factors Group - Bioclinic Naturals, NEM Eggshell Membrane - Helps support…
  853. FDA-2011-N-0921-18652Reference 93_FDA_2012_Guidance for Industry Testing Salmonella in Human and Animal Food re…
  854. FDA-1990-G-0246-0060GLP - Compliance Statement (June 7, 1978)
  855. FDA-2020-N-0908-0005Agency Information Collection Activities; Proposed Collection; Comment Request; Submission…
  856. FDA-2012-S-1144-0137NBTY, Inc. (Green Tea Extract) - Letter
  857. FDA-2014-E-2351-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
  858. FDA-2018-H-4397-0001Complaint
  859. FDA-2015-N-0101-1079Reference 171 - Teratology Study in Rats re Safety and Effectiveness of Health Care…
  860. FDA-2020-E-1256-0001Letter from U S Patent and Trademark Office
  861. FDA-1978-N-0633-0003Accession No. 88-86-05, Box 11 Retired
  862. FDA-2000-P-0412-0015Appendix A: 1984 CHP A Voluntary Inactive Ingredient Labeling Program (reprinted 1996) re…
  863. FDA-2016-H-3109-0001Complaint
  864. FDA-2017-N-6565-0019Reference 2 - HHS SG-2016-E-Cigarette Use Among You
  865. FDA-2023-H-5229-0001Complaint
  866. FDA-2019-P-0941-0001Suitability Petition from Schafer Veterinary Consultants, LLC on behalf of Felix…
  867. FDA-2018-H-3407-0001Complaint
  868. FDA-2022-H-1597-0001Complaint
  869. FDA-2025-E-3625-0001Letter from U. S. Patent and Trademark Office
  870. FDA-2002-N-0233-0190Meeting held in Boston, Massachusetts on April 1, 2004
  871. FDA-2010-N-0001-0088Optimizing Clinical Trial Design for Development of Pediatric Cardiovascular Devices…
  872. FDA-1977-N-0014-0629Letter from Harold F. Sharpe et. al. to Honorable Charles Percy, United States Senate re…
  873. FDA-2022-V-1555-0003Variance Approval from FDA CDRH to Eagle Brook Church
  874. FDA-2025-S-0024-05422025-000628 - Nestle Health Science - 1- Nature's Bounty Optimal Solutions, Ultra Collagen…
  875. FDA-2004-P-0358-0004Letter from FDA CFSAN to Grocery Manufacturers of America
  876. FDA-2021-V-0685-0001Variance Application from New Light Productions
  877. FDA-2011-S-0933-0048NDI 683, TA-65: Cycloastragenol, a Purified Extract from Astragalus Membranaceus from…
  878. FDA-2016-S-0024-2003Source Naturals - Genistein Soy Complex - Isoflavones are unique poly phenol compounds…
  879. FDA-2024-P-2753-0002Acknowledgement Letter from FDA DMS to Hyman, Phelps & McNamara, P.C.
  880. FDA-1980-N-0038-0213Vioform-Hydrocortisone Hearing (Vol 26 of 34)
  881. FDA-2014-V-0334-0002Acknowledgement Letter from FDA DDM to FineLine Multimedia
  882. FDA-2018-V-1169-0002Acknowledgement Letter from FDA DDM to Joseph D Keyes DDS LLC
  883. FDA-2019-S-0024-01842019002164-FoodState (Product ManufacturingWarehouse) - Baby & Me - Supports the health of…
  884. FDA-2015-P-0732-0091[TAB 87] FDA, Petition Response, Docket No. FDA-2007-P-0182 (Oct. 13, 2010)…
  885. FDA-2025-N-1793-0020Reference 18 - U.S. Department of Agriculture and U.S. Department of Health and Human…
  886. FDA-2014-V-0468-0002Acknowledgement Letter from FDA DDM to Allthelighs
  887. FDA-2011-V-0699-0001Dublin Square - Application for Variance
  888. FDA-2013-N-1155-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Food…
  889. FDA-2015-S-0024-1835Michael's Naturopathic Programs - Michael's Naturopathic Programs Daily Immune Factors
  890. FDA-2009-S-0607-1542HEALEO Pure. Simple. Health - Multiple Claims - 88
  891. FDA-2008-P-0558-0005FDA/CDER to Schiff & Company - Letter
  892. FDA-2024-H-5869-0001Complaint
  893. FDA-1984-G-0019-0163Toxicity Data re Supplement from Ad Hoc Enzyme Technical Committee
  894. FDA-1997-S-0039-2253Perrigo Company of South Carolina - HEB - Century Mature - Essential Antioxidants Help…
  895. FDA-2017-H-5075-0001Complaint
  896. FDA-2005-S-0518-0131NDI 298 - Manganese Glucosamine Gluconate - Original NDI Notification
  897. FDA-2017-H-0539-0001CMP Complaint from FDA CTP to 7-Eleven, Inc. d/b/a 7-Eleven 10262
  898. FDA-1981-N-0361-0002Buchanan Ingersoll & Rooney PC to FDA/CDER, February 7, 2011 - Letter
  899. FDA-2024-H-3374-0001Complaint
  900. FDA-2009-S-0607-1489Perrigo Company of South Carolina - H-E-B® - Calcium Citrate + D, Kroger® - Calcium…
  901. FDA-1987-N-0010-0285Background Material
  902. FDA-2007-D-0369-1252PSG_019032 - Draft Guidance on Guanfacine Hydrochloride
  903. FDA-2022-H-2565-0001Complaint
  904. FDA-2017-H-1259-0001CMP Complaint Issued to Jose R. Torres Delgado d/b/a Supermercados Famcoop/Supermercado…
  905. FDA-2024-S-0024-07932024-001656 - NATURAL TARGET LLC - NATURE TARGET, COQ10 200mg - Supports cardiovascular…
  906. FDA-2019-H-3102-0001Complaint
  907. FDA-2020-H-0429-0001Complaint
  908. FDA-2019-S-0024-07432019-3633 Futurebiotics, LLC- Futurebiotics Vitamin K2+D3 Capsules- Supports a healthy…
  909. FDA-2012-N-1210-0002Food Labeling: Revision of the Nutrition and Supplement Facts Labels
  910. FDA-2017-H-1996-0001CMP Complaint Issued to A. E. Robinson Oil Co., Inc. d/b/a A E Robinson Triangle Service
  911. FDA-2025-H-0714-0001Complaint
  912. FDA-2018-D-3583-0008Reference 16_EPA_2001_Potential Cross Contamination Due to Cross Connection and Back-flows…
  913. FDA-2017-D-6554-0001Guidance: Refuse to File-New Drug Application and Biologics License Application…
  914. FDA-2014-V-1751-0011Attachment 1: Instructions for Use and Technical Manual
  915. FDA-2023-S-0024-02732023-000303 - Factors Group of Nutritional Companies Inc. - Name Natural Factors…
  916. FDA-2023-E-1746-0004Letter from U.S. Patent and Trademark Office to FDA CDER
  917. FDA-2020-H-1144-0001Complaint
  918. FDA-2001-D-0058-0001FDA
  919. FDA-2020-V-2150-0001Variance Application from Edmond Slattery
  920. FDA-2020-P-0863-0400Reference 385 Sakamoto et al., 2019 re: Qualified Health Claim Petition from Sevo…
  921. FDA-2016-P-2955-0339Denial letter on petition and petition for reconsideration from FDA OC to Michelle J…
  922. FDA-2013-S-0024-0856Perrigo Company of South Carolina - Multiple Claims - 31
  923. FDA-2020-D-1118-0005Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign…
  924. FDA-1978-N-1713-0003Accession No. 88-86-05, Box 11 Retired
  925. FDA-2013-V-0451-0001Static Entertainment LLC - Application for Variance
  926. FDA-2023-V-2539-0001Variance Application from Kls Solutions
  927. FDA-2019-H-3890-0001Complaint
  928. FDA-2015-S-0024-0997Perrigo Co of South Carolina - Meijer™ - Century - B-Vitamins and Iron facilitate cellular…
  929. FDA-2013-N-0514-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
  930. FDA-2007-P-0170-0006Teva Pharmaceuticals USA - Exhibit 4 - Approved Drug Products
  931. FDA-2006-E-0130-0016FDA/CDER to USPTO - Letter
  932. FDA-2016-S-0024-1616Perrigo Company of South Carolina - Careone® - Joint Health - Vitamin C helps to support…
  933. FDA-1976-N-0525-0131University Of Oregon Health Sciences Center-Office of Research Services - Letter
  934. FDA-2023-H-0510-0001Complaint
  935. FDA-2020-V-1004-0001Variance Application from Source audio Systems LLC
  936. FDA-2016-H-2144-0001Complaint
  937. FDA-2016-V-1627-0001Variance Application from Highway 39 Event Center
  938. FDA-2021-V-0323-0001Variance Application for Guerilla Lasers LLC
  939. FDA-2025-V-0563-0002Variance Acknowledgment Letter from FDA DMB to HAD2
  940. FDA-2014-N-0189-5817Request for Extension from Anonymous
  941. FDA-2023-H-1700-0001Complaint
  942. FDA-1987-N-0010-0147Background Material
  943. FDA-1984-G-0174-0031Memorandum on GRASP 3G0283: Immobilized Glucose Isomerase from Flavobacterium Arborescens
  944. FDA-2020-S-0024-00842020-000103 Phytomatrix Natural Technologies- Hemp for Life - Hot Flash- promotes relief…
  945. FDA-2020-S-0023-0013NDI 1135 - ZBGTECH Holding compound liquid supplement - Original NDI Notification
  946. FDA-1980-N-0038-0335Correction from CIBA-GEIGY( Wald, Harkrader & Ross)
  947. FDA-2015-H-0524-0001Complaint
  948. FDA-1980-N-0049-0132Background Information re Biological Products; Bacterial Vaccines and Toxiods…
  949. FDA-2010-P-0580-0002Exhibit A - "FDA/CDRH Response to Medtronic MiniMed, Apirl 7, 2006" - [Bracewell &…
  950. FDA-2016-E-2179-0007Letter from FDA CDER to U.S. Patent and Trademark Office
  951. FDA-2022-H-2607-0001Complaint
  952. FDA-2018-H-0039-0001Complaint
  953. FDA-2011-S-0932-0545Letter from NBTY, Inc.
  954. FDA-2016-P-1287-0003Attachment 1 Orange Book for Amphotericin B Liposome for Injection, accessed 05/12/16 re…
  955. FDA-1982-N-0011-0077Background Material
  956. FDA-2006-P-0338-0058Attachment 32 - "Hens are Fed on all Natural Whole Grain Diet Rich in Corn and Soy Protein…
  957. FDA-2014-N-0189-6287Request for Extension from Anonymous
  958. FDA-2025-N-2522-0001Medical Device User Fee Rates for Fiscal Year 2026
  959. FDA-2025-P-0343-0002Acknowledgment Letter from FDA DMB to Pharmobedient Consulting, LLC
  960. FDA-2024-V-3718-0001Variance Application from Abigayle Pool
  961. FDA-2011-V-0234-0002Acknowledgement Letter to Integrity Lighting, Inc.
  962. FDA-2022-E-2207-0006Order Granting Interim Extension
  963. FDA-2001-N-0046-0010HFS- 800 to Pear Bureau Northwest (Pear Bureau)
  964. FDA-2022-H-1875-0001Complaint
  965. FDA-2017-H-3010-0001CMP Complaint Issued to H and W Oil Co., Inc. d/b/a Herd’s General Store
  966. FDA-2008-P-0343-0008Exhibit 2 - Product Description [Prandin] re FDA-2008-P-0343-0001 - Labeling
  967. FDA-2024-H-4256-0001Complaint
  968. FDA-2021-P-1144-0009180-Day Interim Response Letter from FDA CFSAN
  969. FDA-2024-H-0723-0001Complaint
  970. FDA-2007-N-0211-0001Timed-Release Drug Products Containing Guaifenesin; Enforcement Action Dates
  971. FDA-2015-D-3581-0009Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and…
  972. FDA-2020-E-2326-0003Patent Term Extension letter from FDA CDER to Honorable Drew Hirshfeld
  973. FDA-2008-D-0205-0048Reference 13 Points to Consider in the Manufacture and Testing of Monoclonal Antibody…
  974. FDA-2014-N-1051-0018016 Protocol amendment #1
  975. FDA-2006-D-0032-0003Draft Guidance
  976. FDA-2006-P-0338-0098Attachment 89 - "Questions and Answers Concerning 483 Inspectional Observations Updated…
  977. FDA-2007-V-0137-0001Acknowledgement Letter to Fyxx Enteraiment
  978. FDA-2019-H-1554-0001Complaint
  979. FDA-2024-H-4012-0001Complaint
  980. FDA-1997-S-0039-1464NOW Foods - Celery Circulation Vcaps - Celery(Apium graveolens) has been cultivated as a…
  981. FDA-2008-D-0233-0025Reference 1 - "Food and Drug Administration, Guidance for Industry: Eligibility…
  982. FDA-1988-P-0242-0004Appendix B Proposed Package Insert and Labeling Cisplatin Injection Pharmachemie B.V. re…
  983. FDA-2018-H-1050-0001Complaint
  984. FDA-2024-E-5100-0006Determination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATH
  985. FDA-2015-H-4063-0001CTP CMP Case re Knoll’s Mobil North LLC d/b/a Knoll’s Mobil North
  986. FDA-2015-H-1766-0001Complaint
  987. FDA-2021-N-0874-0085Letter from FDA CDER to OCS
  988. FDA-2019-H-5107-0001Complaint
  989. FDA-2021-N-0553-1985FG-Ref 21-FDA-Citizen Petition LabelGarlic
  990. FDA-2024-S-0024-07972024-001661 - NATURAL TARGET LLC - NATURE TARGET, Marine Collagen Peptides Powder…
  991. FDA-2009-D-0343-0004International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation…
  992. FDA-2025-H-0549-0001Complaint
  993. FDA-2020-P-0863-0127Reference 111 Dong et al., 2019 re: Qualified Health Claim Petition from Sevo…
  994. FDA-1984-N-0259-0030Exhibit G-3.23 re: Disclosure of Data and Information from Center for Drugs and Biologics…
  995. FDA-2021-P-1085-0004Envelope RE Suitability Petition from Ray Law Firm, PLLC
  996. FDA-2014-S-0024-0417Country Life (Country Life Chewable Adult Multi) - Letter
  997. FDA-2015-H-5087-0001CTP CMP Case re Beach Tobacco and Beer, LLC d/b/a Beach Tobacco and Beer
  998. FDA-2006-P-0390-0001Acknowledgement Letter to Public Citizen's Health Research Group
  999. FDA-2014-P-0159-0003Amendment From Mead Killion to FDA-2014-P-0159
  1000. FDA-2017-H-0213-0001CMP Complaint Issued to Maria Cafeteria, Inc. d/b/a Maria Cafeteria

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