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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2022-S-0024-1050.

1. FDA-2007-D-0369-0730PSG_213138 - Draft Guidance on Fidaxomicin
2. FDA-2005-P-0196-0001SEE FDA-2005-P-0196-0002
3. FDA-1997-S-0006-0993HFS-810 to Neuro Help - Letter - Let 664
4. FDA-2012-S-1144-0634Source Naturals - Epicor with Vitamin D-3 - Energize your immune system with this…
5. FDA-1997-S-0039-2509Perrigo Company of South Carolina - Vitasmart-Magnesium - Magnesium is an Essential…
6. FDA-2007-D-0369-2358PSG_017922 - Draft Guidance on Desmopressin Acetate
7. FDA-2022-V-1138-0003Variance Approval from FDA CDRH to Diamond Event Group LLC
8. FDA-2013-V-1650-0002Acknowledgement Letter from FDA DDM to Looshuss Lasers
9. FDA-2015-D-0025-0015Medical Device Accessories—Describing Accessories and Classification Pathway for New…
10. FDA-2015-H-4225-0001CTP CMP Case re Grace NW Enterprises, Inc. d/b/a Express Mart
11. FDA-2015-H-5019-0001CTP CMP Case re Aliwaeli LLC d/b/a Jefferson BP Gas Station
12. FDA-2018-S-0024-04052018001526- Lacto Health LLC- Lacto Sinus Probiotic Powder- Supports Sinus Health
13. FDA-2016-H-4449-0001Complaint
14. FDA-2025-E-0921-0004Letter from U.S. Patent and Trademark Office to FDA CDER
15. FDA-2024-H-0418-0001Complaint
16. FDA-2020-S-0024-06232020-000772 International Vitamin Corporation - nature's wonder ONE DAILY Women's…
17. FDA-2004-N-0057-0044Transcript of the April 14, 2004 Public Meeting
18. FDA-2016-S-0024-1390Perrigo Company - Shopko®- Acidophilus - Helps promote gastrointestinal health and…
19. FDA-1996-N-0006-0166List of References re Eligibility Criteria for Considering Additional Conditions in the…
20. FDA-2013-S-0024-1026NBTY - Selenium - Antioxidant Support
21. FDA-2023-H-0847-0001Complaint
22. FDA-2004-N-0378-0005Agency Information Collection Activities; Announcement of Office of Management and Budget…
23. FDA-2023-V-4156-0003Variance Approval from FDA CDRH to Concept Electronics, Inc
24. FDA-2016-E-2379-0001Patent Extension Application from Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (on…
25. FDA-2010-S-0664-2620Perrigo - Exchange Select - Glucosamine Chondroitin - Support Healthy Joint Cartilage
26. FDA-2015-M-4344-0001Premarket Approval Response from FDA CDRH to Roche Molecular Systems, Inc. cobas® EGFR…
27. FDA-2016-H-3202-0001Complaint
28. FDA-2018-P-1891-0003Attachment 1 Orange Book re Citizen Petition from PuraCap Pharmaceutical, LLC on behalf of…
29. FDA-2025-H-6232-0001Complaint
30. FDA-2007-P-0289-0005Lachman Consultant Services, Inc. - Attachment 2 - Pkg. Info Zaleplon Capsules
31. FDA-2006-D-0477-0007Guidance
32. FDA-2022-V-0865-0003Variance Approval from FDA CDRH to Garf Enterprises LLC
33. FDA-2016-N-3120-0131redacted_079_202608_Bioequivalence Review
34. FDA-1978-N-0018-0188FDA
35. FDA-1997-S-0006-0336HFS-456 Herbs for Kids, Inc - Letter - Let 46
36. FDA-2024-E-1297-0005Letter from FDA CDER to U.S. Patent and Trademark Office
37. FDA-2025-H-1417-0001Complaint
38. FDA-2022-S-0024-02802022-000264 - Lang Pharma Nutrition Inc. - CVS Health Melatonin + Probiotic - support…
39. FDA-2023-P-4616-0007Interim Response Letter from FDA CDER to Zydus Pharmaceuticals (USA) Inc.
40. FDA-1989-G-0171-0072Enclosures on GRAS Affirmation Petition 9G0355; Lysozyme re Supplement from Keller &…
41. FDA-2017-D-0175-0064Reference 55-Lado_2007_Characteristics of LM important to food processors re Guidance for…
42. FDA-2017-H-3419-0001CMP Complaint Issued to The Carioca Company d/b/a Shell / Minute Mart
43. FDA-2020-V-2073-0003Variance Approval letter from CDRH to Anagram Sound
44. FDA-2023-P-4287-0004Attachment 2 KETALAR re Suitability Petition from Lachman Consulting Services Inc
45. FDA-2016-H-2260-0001Complaint
46. FDA-2022-V-1245-0003Variance Approval from FDA CDRH to Kurt Vierheller
47. FDA-2016-N-3120-0552Full Protocol
48. FDA-2005-N-0168-0001Agency Emergency Processing Under Office of Management and Budget Review; Guidance for…
49. FDA-2020-P-1718-0002Acknowledgment Letter from FDA DMS to Public Health Advocacy Institute, Inc. on behalf of…
50. FDA-2023-H-1447-0001Complaint
51. FDA-2011-S-0932-0975Now Foods (Now Vitamin D-3 1,000 IU Supplements)
52. FDA-2019-H-4317-0001Complaint
53. FDA-2009-P-0156-0003Citizen Petition Denial Letter Response from FDA CFSAN to Paul Stoller, MD
54. FDA-2011-S-0933-0135NDI 700, Krill Oil from Aker Biomarine Antarctic AS
55. FDA-2018-P-1008-0004Attachment 2- Comparative Labeling RLD vs Proposed Drug Product re: Citizens Petition from…
56. FDA-2017-H-5411-0001Complaint
57. FDA-1999-P-2420-0004Attachment 3 Certification Statement from Terry B. Cairns re: Citizen Petition from…
58. FDA-2017-H-5750-0001Complaint
59. FDA-2015-V-0176-0001Variance Application Request from Lumalaser Inc
60. FDA-2016-Q-0995-0002Qualified Health Claim Petition - Soybean Oil and Reduced Risk of Coronary Heart Disease…
61. FDA-2011-S-0932-2467Ganeden Biotech, Inc. - Sustenex Probiotic Gummies - Helping the body maintain a balance…
62. FDA-2016-H-2839-0001Complaint
63. FDA-2023-S-0024-06662023-001417 - OLLY PBC - OLLY Mighty Mojo - Supports Testosterone Production & Healthy…
64. FDA-2012-P-0468-0001Cadila Pharmaceuticals Limited, India (Modavar Pharmaceuticals LLC) - Citizen Petition
65. FDA-2021-V-0511-0001Variance Application from Ghostlight Systems
66. FDA-2019-S-0024-02842019002267 - New Chapter, Inc - Complete Organic Plant Protein + Original (Vanilla)…
67. FDA-2023-H-5033-0001Complaint
68. FDA-2020-E-1904-0002Letter from U.S. Patent and Trademark Office to FDA CDER
69. FDA-2020-S-0024-06292020-000785 TruScience Corp - MyShape - Regulates appetite and inhibits hunger.
70. FDA-2015-S-0024-2692NOW - Artichoke Extract - Digestive health
71. FDA-1997-S-0006-2199Courtesy letter and related material from HFP to HECH Europe GMBH
72. FDA-2015-S-0024-2072NBTY, Inc. - Biotin - Supports healthy hair, skin and nails
73. FDA-2015-N-0101-0359Reference 11-132 - FDA-1975-N-0012-0163 --- C59 Steris_Corporation_Comment re Safety and…
74. FDA-2020-P-1601-0042Attachment 1- Petition for Administrative Action to require placebo control group in…
75. FDA-2011-S-0932-2876NBTY, Inc. - Giant Eagle L-Lysine Supplements - An Amino Acid for Balanced Nutrition &…
76. FDA-2021-P-0893-0036Tab 33 - The United States Pharmacopeia, Twentieth Revision and The National Formulary…
77. FDA-2017-H-6996-0001Complaint
78. FDA-1997-S-0039-2650Amrita Veda, Inc. - Kundali (proprietary blend) - Supports the Immune System
79. FDA-1999-P-0041-0001Memorandum of Telephone Conversation FDA and Proctor & Gamble
80. FDA-2024-S-0024-02882024-000931 - WelsfordAI - WONT Supplements - Helps promote a lower appetite
81. FDA-2024-V-0736-0002Acknowledgment Letter from FDA DMS to Paparazzi Entertainment
82. FDA-2024-H-2805-0001Complaint
83. FDA-2017-H-6222-0001Complaint
84. FDA-1997-S-0039-1700Life Force International - Intestinal Tone - Promotes bowel regularity
85. FDA-2013-N-0001-0129FDA ICCR Public Meeting (May 8 2013) Transcript
86. FDA-2013-S-0024-0874Country Life - Multiple claims - 7
87. FDA-2021-P-0567-0003Attachment 1 Approved Drug Products with Therapeutic Equivalence Evaluations re…
88. FDA-2007-D-0369-1006PSG_203565 - Draft Guidance on Ferric Carboxymaltose
89. FDA-1997-N-0019-0015Duramed Pharm, Inc/Barr Labs., Inc
90. FDA-2012-V-1089-0002Acknowledgement Letter to Quark Lighting & Lasers
91. FDA-2022-D-0109-0014Fostering Medical Device Improvement: Food and Drug Administration Activities and…
92. FDA-2023-H-5552-0001Complaint
93. FDA-2018-D-2238-001716 Reference 15 - Guidance for Industry -Gene Therapy Clinical Trials - Observing Subjects…
94. FDA-2018-P-3372-0001Citizen Petition from Ohio State University
95. FDA-2025-N-2422-0001Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New…
96. FDA-2018-V-0570-0002Acknowledgement Letter from FDA DDM to North East Productions
97. FDA-2017-E-5956-0002U.S. Patent and Trademark Office
98. FDA-1996-P-0056-0001FDA/CVM to Luitpold Pharmaceuticals, Inc. - Letter
99. FDA-2013-V-0393-0001DJ NINO - Application for Variance
100. FDA-2012-S-1178-0143NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods…
101. FDA-1998-N-0007-0003References to NIR
102. FDA-1995-N-0029-0005Food Labeling; Nutrient Content Claims: Definition for “High Potency” and Definitions of…
103. FDA-2013-H-1185-0001Complaint
104. FDA-2011-E-0367-0004U.S. Patent and Trademark Office - Letter
105. FDA-2011-E-0367-0003U.S. Patent and Trademark Office - Letter
106. FDA-2010-S-0664-2189Perrigo - Dolgencorp, LLC DG Health Glucosamine Chondroitin Complex - Support Healthy…
107. FDA-2007-N-0197-0008OTC Adolescent Drug Product Use Speakers
108. FDA-2009-S-0607-1138Perrigo - Onesource Teens Multi - Supports Bone, Skin & Immune Health
109. FDA-2017-N-6565-4840Request for Extension of Comment Period from Voltage Vapin', Inc.
110. FDA-2023-H-4235-0001Complaint
111. FDA-1987-N-0010-0216Background Material
112. FDA-2011-P-0552-0003Robert Wagner to FDA's Division of Dockets Management - Letter
113. FDA-2017-D-0175-0063Reference 54-ICMSF_1996_Chapter 8 Listeria monocytogenes re Guidance for Industry on…
114. FDA-2015-H-3878-0001CTP CMP Case re Northern Fuel, Inc. d/b/a College Way Chevron
115. FDA-2006-N-0309-0005Supporting Statement for General Licensing Provisions; Biologics License Application…
116. FDA-1976-N-0027-0186Supplement from Consumer Healthcare Products Association - Appendix 3: Part 2
117. FDA-2015-F-0537-0013Attachment 3 Supplement from Natural Resources Defense Council re: Comment from Tom…
118. FDA-2016-Q-0274-0011Reference 7- Statement of Endorsement re Qualified Health Claim Petition from Contract…
119. FDA-2025-H-3364-0001Complaint
120. FDA-2019-H-2049-0001Complaint
121. FDA-2010-D-0462-0002Guidance for Industry on Chronic Hepatitis C Virus Infection; Developing Direct-Acting…
122. FDA-1994-P-0041-0111BACKGROUND
123. FDA-2023-H-4999-0001Complaint
124. FDA-2015-S-0024-1021USANA Health Sciences - Palmetto Plus - Supports long-term prostate health
125. FDA-2023-P-3766-0012Interim Response Letter FDA CDER to University of Illinois, College of Pharmacy
126. FDA-2025-S-0024-01152025-000163 - Reliance Vitamin Co. - Ultra DIM 200 mg- PROMOTES HEALTHY HORMONAL BALANCE &…
127. FDA-2018-D-2258-0030Reference 19 Expedited Programs for Regenerative Medicine re Human Gene Therapy for Rare…
128. FDA-1996-N-0273-0002Reply to Exception from FDA re: United States v. Century Clinic, Inc., et al.
129. FDA-2005-D-0158-0004Guidance
130. FDA-2024-D-3863-0011Reference 8 - Miramontes, R., et al., Tuberculosis Infection in the United States…
131. FDA-2013-D-1319-0001Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment…
132. FDA-2019-N-1482-4335Viner, Mark. Mark W Viner MD PLLC
133. FDA-2014-N-0189-3254Request for Extension from Anonymous
134. FDA-2017-H-0322-0001Complaint from FDA CTP to Phillips and Munzel Oil Co., Inc. d/b/a Marathon
135. FDA-2022-H-1237-0001Complaint
136. FDA-2018-V-0382-0001Variance Application for R&N Productions
137. FDA-2014-N-0189-9081Request for Extension from Anonymous
138. FDA-2004-P-0214-0026References for Citizen Peition Response
139. FDA-2013-N-0227-0363Request from Extension from North Carolina Farm Bureau Federation, Inc.
140. FDA-2018-N-0188-0125Reference ADCOMM - 2016-06-08 - FDA presentation (CDC Guidelines)
141. FDA-2013-N-0500-0112Transcript of March 27 2015 Supplemental Applications Proposing Labeling Changes for…
142. FDA-2009-N-0294-1148Attorney General of Washington to the Squaxin Island Tribe - Letter
143. FDA-2024-D-2604-0001Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking…
144. FDA-2014-N-0189-0530Request for Extension from the Pipe Tobacco Council
145. FDA-2021-N-1349-0427PRIA Reference 118 US Census Bureau All Sectors Industry by Products 2017
146. FDA-1995-P-0016-0064Background Material in 94P-0390
147. FDA-1984-N-0259-0486Certificate of Service re: Reply to Mead Johnson’s Exceptions from FDA
148. FDA-2016-M-2651-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
149. FDA-2019-P-2869-0001Citizen Petition from Valisure, LLC.
150. FDA-2022-E-0762-0005Letter from FDA CDER to U. S. Patent and Trademark Office
151. FDA-2024-N-5471-0529Reference 527 British American Tobacco Introductory Notes on Leaf Blending 1969
152. FDA-2013-P-1612-0082Acknowledgement Letter from FDA/DDM to Richard Stricker
153. FDA-2013-S-0024-0912NOW Foods - IGF-1 Lozenges - All Natural Growth Factor
154. FDA-2024-V-4986-0001Variance Application from Novo Experiences LLC
155. FDA-2014-P-0513-0001Citizen Petition From University of TX MD Anderson Cancer Center
156. FDA-2016-D-1399-0002Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation…
157. FDA-1984-G-0007-0021Background Material: Report E-18 IFREB
158. FDA-2013-V-1209-0003FDA/CDRH Response to PRANA - Approval of Variance
159. FDA-2025-H-5571-0001Complaint
160. FDA-2020-H-0182-0001Complaint
161. FDA-2010-N-0099-0009Revision of the Requirements for Constituent Materials
162. FDA-2016-H-2636-0001Complaint
163. FDA-1978-N-1131-0001Classification of Colonic Irrigation Systems - Notice of Proposed Rule
164. FDA-1997-S-0039-2915Perrigo - Nature's Code Men Over 50 - Maintain Strong Bones and Support a Healthy Immune…
165. FDA-2018-P-1349-0007Petition Response Letter from FDA CVM to Douglass Oeller Consulting, Inc.
166. FDA-2021-V-0154-0001Variance Application from Rich Music, Inc.
167. FDA-2016-V-1206-0001Variance Application from North Hialeah Baptist Church
168. FDA-2023-H-3813-0001Complaint
169. FDA-1997-S-0006-0823HFS-810 to Market America Inc. - Letter - Let 512
170. FDA-1978-N-1501-0004Accession No. 88-86-09, Box 4 - Retired
171. FDA-2023-V-0292-0001Variance Application from Light Up the Night
172. FDA-2011-N-0146-0211Reference 16: Zheng, Y., Muth, M.M., Kosa, K., “Economic Analysis of Third-Party Food…
173. FDA-2020-H-0582-0001Complaint
174. FDA-2021-N-0002-0023FOI Summary cN 141-526 approved January 11 2021 RE: New Animal Drugs; Approval of New…
175. FDA-2015-S-0024-1432Solstice Medicine Co - Sanqi Capsule Herbal Supplement - Heart, Cardiovascular and Blood…
176. FDA-2002-N-0318-0010Transcript for the 04/11/2003
177. FDA-2006-S-0544-0170NDI 361 - Absolbotani - SUPPORTING & RELATED MATERIALS
178. FDA-2010-N-0104-0002Reference 1 - Presidential's Food Safety Working Group Findings [FDA-2010-N-0104-0001]
179. FDA-2015-S-0024-3538Perrigo Company of South Carolina - Meijer™- E - Vitamin E is an antioxidant. It works to…
180. FDA-1978-N-0018-0436Letter from FDA/CDER to The Cosmetic, Toiletry & Fragrance Association
181. FDA-2002-D-0086-0006Guidance
182. FDA-1998-N-0051-0123Attachment 2 Tylenol Label re: Application for Exemption from McNeil Consumer Healthcare
183. FDA-2015-P-0403-0002Acknowledgement Letter from FDA DDM to LACHMAN CONSULTANT SERVICES INC
184. FDA-2022-V-1931-0003Variance Approval Letter from FDA CDRH to MZ Productions
185. FDA-2004-V-0432-0003HFA-305 to Jose Ayala
186. FDA-2025-S-0024-08092025-000909 - Factors Group of Nutritional Companies Inc - Natural Factors, DGL…
187. FDA-2007-N-0259-0009Carey, Carole
188. FDA-2018-S-0024-06732018-4255 Mylan Consumer Healthcare, Inc.- DONA, 750 mg- maintain the normal function of…
189. FDA-2024-V-1761-0004Variance Approval Letter from FDA CDRH to 1851 Club
190. FDA-2016-S-0024-0510Grass Advantage Inc, (DBA Amazing Grass) - The Amazing Trio - Supports healthy immune and…
191. FDA-2003-D-0305-0003GUIDANCE
192. FDA-2016-P-3313-0002Acknowledgment Letter from FDA DDM to Kleinfeld, Kaplan and Becker, LLP
193. FDA-1995-P-0011-0001Withdrawal of Approval of 128 Suitability Petitions
194. FDA-2025-R-6236-0001Complaint
195. FDA-2016-H-1599-0001Complaint
196. FDA-2007-D-0369-0859PSG_213426 - Draft Guidance on Celecoxib; Tramadol Hydrochloride
197. FDA-2021-P-0338-0019Minutes of Meeting with Valisure, LLC
198. FDA-2016-H-3714-0001Complaint
199. FDA-2020-E-1840-0006Letter from FDA CDER to U.S. Patent and Trademark Office
200. FDA-2014-N-0595-0166Reference 15 - EPA Integrated Risk Information System re Advice About Eating Fish, From…
201. FDA-2023-V-0799-0002Acknowledgment Letter from FDA DMS to Ryan Key
202. FDA-1997-S-0006-0025See FDA-1997-S-0006-0022
203. FDA-2020-N-2029-02072022-03-25 CDER Transmittal Letter - O Brien Correspondence
204. FDA-2014-P-2188-0022Exibit T
205. FDA-2015-S-0024-3033ProCaps Laboratories - Fiber Benefits - helps to "scour" the digestive tract, removing…
206. FDA-2014-H-0413-0001Complaint
207. FDA-2016-P-1250-0005Interim response from CDER to PTS Consulting LLC
208. FDA-2020-H-0972-0001Complaint
209. FDA-2011-S-0932-2071Vitacost.com, Inc., d/b/a Nutraceutical Sciences Institute - Smart Basics Organic…
210. FDA-1984-G-0019-0113Letter from FDA/HFS-216 to Genencor International, Inc.
211. FDA-2021-N-1349-0506PRIA Reference 197 Cutler Valuing Regulations Affecting Addictive or Habitual Goods 2015
212. FDA-1999-N-0137-0001Agency Information Collection Activities: Proposed Collection; Comment Request; Infant…
213. FDA-2014-E-0130-0008Insect cell glycosylation patterns in the context of biopharmaceuticals
214. FDA-2015-M-3256-0001Premarket Approval Response from FDA CDRH to Fidia Farmaceutici, S.p.A. HYMOVIS®
215. FDA-2016-H-2041-0001Complaint
216. FDA-2010-P-0339-0023Richard F. Edlich, M.D., Ph.D., (University of Virginia Health System) - Supplement
217. FDA-2017-R-0593-0001Complaint from FDA CTP to 8 Merchants, LLC d/b/a 7-Eleven 35532A
218. FDA-2014-P-0823-0010Letter from Richard D. Burk to FDA CDER
219. FDA-2020-V-0922-0002Acknowledgment Letter from FDA DMS to Leonard Sasso
220. FDA-2022-H-1475-0001Complaint
221. FDA-2012-S-1144-1774OmNutrition, Inc. - Omega 3 Complete - May Help Reduce The Risk Of Coronary Heart Disease
222. FDA-2014-E-0071-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
223. FDA-1997-S-0039-1683Letter from Perrigo Company of South Carolina - Heart Health
224. FDA-2009-P-0070-0003APP Pharmaceuticals, LLC - Supplement
225. FDA-2019-H-5249-0001Complaint
226. FDA-2020-P-1246-0001Citizen Petition from Fresenius KabiUSA, LLC
227. FDA-2004-N-0381-0005Supporting Statement for Information Collection Voluntary Registration of Cosmetic Product…
228. FDA-2017-H-2545-0001CMP Complaint Issued to Sulaiman Metalwala, d/b/a Starzz Sundries and Gifts
229. FDA-1997-S-0006-0765HFS-810 to Mannatech, Inc. - Letter - Let 454
230. FDA-1997-S-0006-0698HFS-456 to NOW Foods - Letter - Let 387
231. FDA-2022-V-1291-0001Variance Application from Glenn Stephens
232. FDA-2019-S-0024-05942019-2671 Schwabe North America - MULTIPLE CLAIMS (4)
233. FDA-2015-H-5096-0001CTP CMP Case re ANDREWJAMES, LLC d/b/a The Dog House Pub
234. FDA-2014-H-1770-0001Complaint
235. FDA-2013-S-0024-1059Perrigo - Meijer™- MegaKrill - Heart Health
236. FDA-2002-N-0030-0002Agency Information Collection Activities; Proposed Collection; Comment Request; Export of…
237. FDA-2015-H-3568-0001CTP CMP Case re Lucrative Business, Inc. d/b/a Cigar Plus
238. FDA-2016-S-0024-1614Perrigo Company of South Carolina - Shopko® - L-Lysine - Helps support healthy skin…
239. FDA-1978-N-0716-0001Memorandum from FDA/CDER to DDM dated February 5, 1979
240. FDA-2025-V-1126-0002Variance Acknowledgment Letter from FDA DMB to Ian Crosson
241. FDA-2023-V-4592-0003Variance Approval Letter from FDA CDRH to M2 Multimedia Inc.
242. FDA-2018-S-0024-04032018001524- Jarrow Formulas, Inc.- Jarrow Formulas® Artichoke (Resubmission [Previous…
243. FDA-2014-N-0189-5756Request for Extension from Anonymous
244. FDA-2003-S-0732-0018NDI 125 - NKCP (Extract of Natto) from Lane Labs-USA
245. FDA-1976-N-0476-0343Memorandum of Telephone Conversation between Dr. R. Williams, Commercial Solvents Corp and…
246. FDA-2019-H-3525-0001Complaint
247. FDA-1999-N-0114-0007Notice of Approval re Agency Information Collection Activities; Announcement of Office of…
248. FDA-2009-N-0664-0134Anesthetic and Life Support Drugs Advisory Committee; Cancellation
249. FDA-2011-S-0933-0192HGH Pharmaceuticals (PTY) Ltd., Sceletium Tortuosum Extract (Zembrin) re Section 3…
250. FDA-2004-N-0130-0003Supporting Statement Registration of Producers of Drugs and Listing of Drugs in Commercial…
251. FDA-2024-N-5784-0001Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act…
252. FDA-2016-Q-1523-0158Sevo denial letter_FINAL_optimized and searchable_Dec 12_2018
253. FDA-1980-N-0049-0150Background Information re Biological Products; Bacterial Vaccines and Toxiods…
254. FDA-2015-S-0024-0496Perrigo - Smart Sense® - Glucosamine & Chondroitin Complex - helps support Joint Comfort
255. FDA-2015-S-0024-1976Waterpure Inc - MuffinStop™ - Effective for weight and waist size management
256. FDA-1990-S-0006-0076Statistical Report - Month of March 2004
257. FDA-2012-D-0530-0035Agency Information Collection Activities; Announcement of Office of Management and Budget…
258. FDA-1994-P-0043-0005FDA
259. FDA-2012-P-1112-0012Citizen Petition Denial Response from FDA CDER to Nobel Laboratories, LLC
260. FDA-2019-H-0274-0001Complaint
261. FDA-2015-N-0101-0656Reference 12-95 - FDA-1975-N-0012-0184 --- CP6 75N-0183H re Safety and Effectiveness of…
262. FDA-2016-H-0989-0001CTP CMP Case re Han's Corporation d/b/a AM/PM Arco 5435
263. FDA-2019-H-1627-0001Complaint
264. FDA-2015-E-2570-0004Letter from U.S. Patent and Trademark Office to CDER
265. FDA-1997-S-0006-0783HFS-810 to Pharmavite Corporation (Kleinfeld, Kaplan & Becker) - Letter - Let 472
266. FDA-2018-H-3253-0001Complaint
267. FDA-1991-N-0077-0001Cooperative Research and Development Agreement Between Nicolet Instrument Corp. and the…
268. FDA-2023-N-2680-0001Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request…
269. FDA-2022-H-2927-0001Complaint
270. FDA-2023-N-3902-0470Comment from Dawn Klein
271. FDA-2020-P-1601-0027Petition for Stay of Action from Siri & Glimstad LLP on behalf of Informed Consent Action…
272. FDA-1997-S-0006-1919Courtesy letter and related material from CFSAN to Swanson Health Products (11658148874)
273. FDA-2014-V-0922-0001Variance Application from Advanced Entertainment Technologies, Inc.
274. FDA-2011-N-0921-18657Reference 98_Bureau of Economic Analysis_Web re Standards for the Growing, Harvesting…
275. FDA-1997-S-0006-1047[LET1011] CFSAN/ONLDS Response to Doctor's Research, Inc. - Courtesy Letter
276. FDA-2025-P-1026-0010Response Letter
277. FDA-1977-N-0002-1120Answer Letter from FDA/Office of Legislative Services to Honorable Robert K. Dornan, House…
278. FDA-2005-P-0316-0004Citizen Petition from Skadden, Arps, Slate, Meagher & Flom LLP on behalf of…
279. FDA-2016-P-3070-0003Appendix Table 1a - LAXATION - Human Clinical Studies with Soy Fiber - Healthy re Citizen…
280. FDA-2022-V-0450-0005Variance Renewal Approval from FDA CDRH to Big Arts Organization, Inc.
281. FDA-2009-D-0187-0002Guidance for Prior notice of Imported Food Shipments - Guidance
282. FDA-2019-E-5273-0006Letter from U. S. Patent and Trademark Office to FDA CDER
283. FDA-2018-H-4888-0001Complaint
284. FDA-2023-H-2936-0001Complaint
285. FDA-2025-E-1674-0002Patent Extension Application from GlaxoSmithKline Biologicals SA
286. FDA-2004-E-0331-0003FDA/CDER to the USPTO - Letter
287. FDA-2022-H-3381-0001Complaint
288. FDA-2014-N-0189-9668Request for Extension from Enrique
289. FDA-2000-E-0022-0001Determination of Regulatory Review Period for Purposes of Patent Extension; KEPPRA
290. FDA-2005-N-0230-0007Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation…
291. FDA-2004-E-0143-0007U.S. Patent and Trademark Office to Eli Lilly and Company
292. FDA-2022-H-0191-0001Complaint
293. FDA-1995-E-0065-0002Patent Term Extension Application from Bristol-Myers Squibb Company
294. FDA-2023-P-0233-0011Interim Response from FDA CDRH to Soft Lights Foundation
295. FDA-2022-E-2142-0007Letter from FDA CDER to U. S. Patent and Trademark Office
296. FDA-2016-S-0024-0840Perrigo - Promotional - Vitamin D helps the body absorb calcium
297. FDA-1980-N-0004-0008Acknowledgement Letter to Ferenc Kuhn, M.D., Ph.D. and Wendell J. Scott M.D.
298. FDA-2020-D-1939-0001CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements
299. FDA-2008-V-0624-0003FDA/CDRH to Eastman Kodak Co. - Approval for Variance
300. FDA-2017-D-0113-0010The Prohibition of Distributing Free Samples of Tobacco Products; Guidance for Industry…
301. FDA-2024-P-2753-0001Suitability Petition from Hyman, Phelps & McNamara, P.C.
302. FDA-2022-S-0024-02572022-000251 - Santa Cruz Nutritionals- Spring Valley Melatonin 5mg Gummies- support more…
303. FDA-1993-G-0220-0020Appendix 5 - Estimated Intake of Lactitol
304. FDA-2024-V-5758-0003Variance Approval Letter from FDA CDRH to JBLLE LLC
305. FDA-2024-S-0024-08402024-001712 - THE NEW HEALTHY LLC - LOTFLY Happy Slim - Helps to Support Stress Levels and…
306. FDA-2005-N-0107-0002Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
307. FDA-2009-S-0607-0302Perrigo - Vitasmart Multi-Vitamins & Publix Women's Multivitamins - Bone Strength
308. FDA-1977-N-0014-1300Answer from FDA/Center for Veterinary Medicine to Comment from Mrs. J. Howard Conover
309. FDA-2012-V-0568-0003FDA/CDRH Letter to Icon Media, Inc. - Approval for Variance
310. FDA-1977-N-0014-0916Answer Letter from FDA to Comment from The Honorable David L. Cornwell, United States…
311. FDA-2013-D-0286-0017Agency Information Collection Activities; Submission for Office of Management and Budget…
312. FDA-1986-E-0030-0001Letter from U.S. Patent and Trademark Office to FDA Office of Health Affairs
313. FDA-2016-P-1169-0010Appendix C re Petition for Reconsideration from e5 Pharma, LLC
314. FDA-2015-V-0269-0002Acknowledgement Letter from FDA DDM to PASTORE MUSIC
315. FDA-2015-S-0024-1567NBTY - Devil's Claw supplements - Traditionally used for joint health
316. FDA-2025-P-6831-0018VOL 6 Part 6 Ftn_ 64
317. FDA-2009-S-0607-0997NOW Foods - Passion Flower Extract 350 mg Vcaps - Natural Stress Relief
318. FDA-2024-P-5378-0004Attachment 2
319. FDA-2011-P-0064-0006Exhibit 5 - "Stipulation of Dismissal, July 14, 2009" - [Barbara L. Maw, P.C. - Citizen…
320. FDA-2015-H-4355-0001CTP CMP Case re Carriage Stop Beer, LLC d/b/a Carriage Stop Plaza / Sunoco
321. FDA-2022-H-2518-0001Complaint
322. FDA-2017-N-2021-0007Agency Information Collection Activities; Proposals, Submissions, and Approvals
323. FDA-2023-V-3614-0001Variance Application from Bradley Stockdale
324. FDA-2024-H-0747-0001Complaint
325. FDA-2007-D-0375-0002Guidance
326. FDA-2011-N-0424-0009Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary…
327. FDA-2024-S-0024-09622024-001837 - The Procter and Gamble Company - Align Women's Dualbiotic Prebiotic +…
328. FDA-2025-H-2528-0001Complaint
329. FDA-2004-Q-0207-0030HFS-800 to Emord & Associates P.C.
330. FDA-2017-P-4174-0009Attachment G Praxair Distribution, Inc vs Mallinckrodt Hospital Products IP Ltd re Citizen…
331. FDA-2024-H-1924-0001Complaint
332. FDA-2014-N-1960-0009Agency Information Collection Activities; Announcement of Office of Management and Budget…
333. FDA-2020-P-1423-0024Appendix 12a Oct 2012 wax content of EVOO from Argentina re Citizen Petition from North…
334. FDA-1999-P-0108-0001Notice - Gastroenterology-Urology Devices; Denial of Request for Change in Classification…
335. FDA-2016-N-3120-0351Letter from FDA to Counsel for the Center for Drug Evaluation and Research (CDER)
336. FDA-2017-H-4992-0001CMP Complaint Issued to Hump U Inc. d/b/a Humptulips Grocery Store
337. FDA-2017-H-1133-0001CMP Complaint Issued to Sobe Prime Tobacco LLC d/b/a Sobe Prime Tobacco / Cigars
338. FDA-2024-V-0466-0003Variance Approval from FDA CDRH to Cdc LLC
339. FDA-2025-H-3271-0001Complaint
340. FDA-2004-P-0467-0033Reference 3: DHHS, National Institute of Dental and Craniofacial Research, "Oral Health in…
341. FDA-1987-P-0272-0004Acknowledgement Letter from FDA/DDM to Victor Herbert, M.D., J.D.
342. FDA-2004-S-0442-0001FDA
343. FDA-2014-E-2345-0004Letter from FDA CDER to the U.S. Patent and Trademark Office
344. FDA-2022-E-0780-0006Letter from FDA CDER to U. S. Patent and Trademark Office
345. FDA-2000-P-0126-0134Compliance Extension Request Response Letter from FDA CFSAN to International Dairy Foods…
346. FDA-2015-S-0024-0361FoodScience Corporation - Immuno Benefits™ (DaVinci Laboratories of Vermont) - A Dietary…
347. FDA-1997-S-0039-1240Nature's Answer - Liquid Sambucus Immune Support - for enhanced Immune support
348. FDA-1975-N-0012-078916-5-3-multianalyte-reanalysis-batches-data
349. FDA-2018-P-1197-0002Acknowledgment Letter from FDA DDM to Exela Pharma Sciences
350. FDA-2017-V-2298-0001Variance Application from Integrity Lighting Inc
351. FDA-2023-H-4656-0001Complaint
352. FDA-2017-H-3382-0001CMP Complaint Issued to Wal-Mart Stores East, LP d/b/a Wal-Mart Supercenter 3307
353. FDA-2025-P-3956-0082Kjaersgaard, M.I., Parner, E.T., Vestergaard, M., Sorensen, M. J., Olsen, J., Christensen…
354. FDA-2019-V-6010-0003Variance Approval Letter from FDA CDRH to Bradford Kellogg
355. FDA-2024-H-1059-0001Complaint
356. FDA-2018-H-1280-0001Complaint
357. FDA-1996-N-0049-0012Background Material
358. FDA-2019-H-2635-0001Complaint
359. FDA-2021-V-0209-0002Acknowledgment Letter from FDA DMS to Tandem Marketing Inc
360. FDA-2019-V-1436-0001Variance Application from Sparx's Hardwood
361. FDA-2009-S-0607-0605Perrigo - Berkley & Jensen Children's Chewable - May Support Healthy Brain Function
362. FDA-2014-H-2178-0001Complaint
363. FDA-2021-N-1349-0524PRIA Reference 215 US Department of Agriculture Crop Production Annual Summary 2021
364. FDA-2014-D-1856-0003Reference List re Human Cells Tissues, and Cellular and Tissue Based Products HCTPs From…
365. FDA-2017-P-1039-0002Acknowledgement Letter from FDA DDM to Beck & Thomas, P.C.
366. FDA-1994-P-0041-0223BACKGROUND
367. FDA-2012-P-0507-0008FDA/CDER to Cumberland Pharmaceutical Inc. (Covington & Burling) - Petition Denial
368. FDA-2015-S-0024-0129NBTY Inc - Quick Dissolve Melatonin supplements - Sleep aid
369. FDA-2024-P-5965-0002Acknowledgement Letter from FDA DMB to Herpes Heroes
370. FDA-1990-G-0246-0119Annex 4 - Determination of Tannin In the Biocatalyst
371. FDA-2021-P-1211-0009Agency Response Letter from FDA CDER to Axinn
372. FDA-2020-D-1959-0001Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient…
373. FDA-2016-S-0024-1225Healthy Directions - Dr. Sinatra Omega-3 SLIM® - Boosts metabolism for healthy weight loss
374. FDA-2011-S-0933-0186HGH Pharmaceuticals (PTY) Ltd., Sceletium Tortuosum Extract (Zembrin) re Name of the New…
375. FDA-2016-E-0532-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
376. FDA-2015-H-4976-0001CTP CMP Case re Terry Little d/b/a Y-Knot Quick Stop
377. FDA-2025-P-1807-002616 - GAO 21 108 DEFENSE PRODUCTION ACT Opportunities Exist to Increase Transparency and…
378. FDA-2015-H-4095-0002Complaint
379. FDA-2012-P-0404-0002Acknowledgement Letter to Public Citizen Health Research Group
380. FDA-2009-S-0607-1406Perrigo - Equaline Century - Immune Support
381. FDA-2012-E-1235-0007Letter from FDA CDER to the U.S. Patent and Trademark Office
382. FDA-2010-S-0664-2171Perrigo - Target Up & Up Teen for Her and Safeway One Daily - Supports Immune System…
383. FDA-2025-P-1154-0001Suitability Petition from Windels Marx Lane & Mittendorf, LLP
384. FDA-2006-S-0544-0197NDI 370 - Extract of Phellinus linetus Mycelium – SUPPORTING & RELATED MATERIALS
385. FDA-2014-E-2325-0004Letter from FDA CDER to the U.S. Patent and Trademark Office
386. FDA-2024-S-0024-07952024-001659 - NATURAL TARGET LLC - NATURE TARGET, Collagen Peptide Powder - Support Skin…
387. FDA-2020-P-1220-0002Acknowledgment Letter from FDA DMS to C Laser Inc
388. FDA-2024-V-4286-0003Variance Approval Letter from FDA CDRH to Laser Kid Productions
389. FDA-2013-S-0009-0001See Document ID FDA-2012-N-1258-0001
390. FDA-2023-V-2681-0002Acknowledgment Letter from FDA DMS to Technobeeztv
391. FDA-2019-R-5591-0001Complaint
392. FDA-2020-V-1096-0002Acknowledgment Letter from FDA DMS to Carrollwood Day School
393. FDA-2015-V-1389-0002Acknowledgement Letter from FDA DDM to Surreality
394. FDA-2006-E-0196-0009Patent Term Extension Application - Exhibit D - Terminal Disclaimer
395. FDA-2007-D-0369-0586Draft Guidance on Colesevelam Hydrochloride; Revised Guidance; PSG_021176
396. FDA-2020-P-1864-0003Interim Response Letter from FDA CDRH to Kambiz Tajkarimi
397. FDA-2013-P-1375-0001Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition
398. FDA-2021-V-1350-0004Variance Approval Letter from FDA CDRH to Optoma Technology Inc.
399. FDA-2007-D-0369-0764PSG_210134 - Draft Guidance on Glucagon
400. FDA-2014-V-1119-0003Variance Approval from FDA CDRH to ROCKSTAR PRODUCTIONS
401. FDA-2023-H-4192-0001Complaint
402. FDA-2025-E-5206-0001Letter from U.S. Patent and Trademark Office to FDA CDER
403. FDA-2021-N-0310-0006Reference 1 - D - Spinal Spheres Devices Roster
404. FDA-2008-S-0663-0054CompeteGest Proprietary Plant Enzyme Blend Protease
405. FDA-1977-N-0014-1357Answer Letter from FDA to Comment from The Honorable Richard (Dick) Stone, United States…
406. FDA-2014-N-0189-5350Request for Extension from Anonymous
407. FDA-2019-H-4083-0001Complaint
408. FDA-2024-V-0137-0001Variance Application from Hermary's LLC
409. FDA-2024-V-0252-0002Acknowledgment Letter from FDA DMS to Ashley Adkins
410. FDA-2013-N-0523-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
411. FDA-1997-S-0039-1218Letter from Perrigo Company of South Carolina
412. FDA-2018-H-3298-0001Complaint
413. FDA-2022-V-1934-0002Acknowledgment Letter from FDA DMS to Waterworks Pub
414. FDA-2023-H-1018-0001Complaint
415. FDA-2012-D-1057-0001Draft Guidance for Industry and Staff; Availability: Highly Multiplexed…
416. FDA-2005-N-0094-0056Electronic Request for Appearance for Pursley-Crotteau, Suzanne
417. FDA-2022-S-0024-07412022-000779 - Nutranext - Rainbow Light Men's One 50+ Daily High Potency Multivitamin…
418. FDA-1998-N-0051-0109Appendix D Labeling Supplied with the BACTEC Blood Cultural Procedural Tray re…
419. FDA-2015-H-3822-0001CTP CMP Case re Ol’ Country Store of West Virginia LLC d/b/a Ol’ Country Store
420. FDA-2017-V-2097-0003EGGSHELL LIGHTING COMPANY, INC RH17A0074 2017-V-2097 LDS LLS Variance Approval 04142017
421. FDA-2021-S-0024-14422021-001587 - Renew Life- Renew Life, Occasional Constipation Support* 20 Billion CFU (60…
422. FDA-2014-N-0189-5214Request for Extension from Anonymous
423. FDA-2016-S-0024-0636NBTY - Vitamin D3 supplements - Supports bone, teeth and immune health
424. FDA-2014-N-1051-0619619 7694105 Survey Subject R1030_Redacted
425. FDA-2005-N-0161-0005FDA
426. FDA-2023-V-0358-0002Acknowledgment Letter from FDA DMS to Le Nocturne
427. FDA-2024-H-4671-0001Complaint
428. FDA-2021-S-0024-10332021-001326 - ChildLife Essentials - ChildLife Essentials, Prenatal DHA - supports a…
429. FDA-2023-P-4285-0006Completeness Assessment Correspondence
430. FDA-2014-V-1663-0001Variance Application from Sound Extreme Productions
431. FDA-2021-S-0024-09912021-001285 - Schwabe North America Inc- MULTIPLE CLAIMS (2)
432. FDA-2015-H-0137-0001Complaint
433. FDA-2017-S-0024-04852017-5988 Nutrition Express - Lindberg® Alpha-Lipoic Acid 100 mg - Supports antioxidant…
434. FDA-2019-H-2760-0001Complaint
435. FDA-2017-H-6490-0001Complaint
436. FDA-2017-H-1921-0001CMP Complaint Issued to Esco Energy Group, Inc. d/b/a Puma San Isidro
437. FDA-2012-S-1144-1970NBTY Inc - Complete Multi 50 Plus Multivitamin Multimineral - Cellular Health
438. FDA-2020-V-2125-0002Acknowledgment Letter from FDA DMS to Victor Escobedo
439. FDA-2010-S-0664-2416Perrigo - H-E-B Multiple Vitamins - Support Physical and Mental Energy
440. FDA-2015-N-0101-0815Reference 19 - FDA-1975-N-0012-0102 --- C30 1975N-0183H veg oil et al6 re Safety and…
441. FDA-2017-H-3253-0001CMP Complaint Issued to Isbania Investments, Inc. d/b/a Harper Liquor Land
442. FDA-2019-H-4022-0001Complaint
443. FDA-2012-P-0984-0001Sheppard Mullin Richter & Hampton LLP - Citizen Petition
444. FDA-2017-H-5010-0001Complaint
445. FDA-2023-V-2538-0003Variance Approval from FDA CDRH to Centerpoint Church
446. FDA-2025-P-1073-0002Acknowledgement Letter from FDA DMS Troutman Pepper Locke LLP on behalf of Logic…
447. FDA-2011-N-0002-0123Preparation for International Conference on Harmonization Steering Committee and Expert…
448. FDA-2019-H-0294-0001Complaint
449. FDA-2011-S-0932-2201NBTY, Inc. - Ginkgo Biloba with Vinpocetine - Supports Alertness
450. FDA-2006-E-0061-0001USPTO to FDA/CDER - Letter
451. FDA-2024-V-2024-0002Acknowledgment Letter from FDA DMS to Ethan Hood
452. FDA-2023-V-5566-0003Variance Approval Letter from FDA CDRH to Roman Nakielny
453. FDA-1975-N-0012-0344FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
454. FDA-2015-H-0466-0001Complaint
455. FDA-2016-D-1113-0058Data Integrity and Compliance With Drug Current Good Manufacturing Process: Questions and…
456. FDA-1978-N-0597-0001X-Ray Intensifying Screens; Notice of Intent to Develop a Radiation Protection…
457. FDA-2009-S-0607-1204Perrigo - Welby Complete - Helps Promote a Healthy Heart
458. FDA-2014-N-0189-3212Request for Extension from Anonymous
459. FDA-1976-N-0031-0106Exhibit 1: Supporting material re Comment from Dorsey Laboratories
460. FDA-2018-H-3617-0001Complaint
461. FDA-2003-N-0154-0009Agency Information Collection Activities; Announcement of Office of Research Study…
462. FDA-1977-N-0014-1362Answer Letter from FDA to Comment from American Sheep Producers Council, Inc.
463. FDA-2007-P-0128-0001Acknowledgement Letter to King Pharmaceuticals, Inc.
464. FDA-2023-S-0024-01152023-000249 - International Vitamin Corporation- Equate Inner Ear Health Plus Dietary…
465. FDA-2010-S-0664-0362Waterpure, Inc. d/b/a Purity Products - Perfect Multi Advanced Liquid Multivitamin…
466. FDA-2019-H-2479-0001Complaint
467. FDA-1977-N-0028-0006Tab 21: Ehrenberg, L. and A. Gustafsson, "On the Mutagenic Action of Ethylene Oxide and…
468. FDA-2010-E-0406-0001NeurogesX, Inc. - Patent Extensio Application
469. FDA-2019-P-5191-0003Appendix 1 Proposed Regulations re: Citizen Petition from American Olive Oil Producers…
470. FDA-2018-H-1926-0001Complaint
471. FDA-2017-H-3141-0001CMP Complaint Issued to Fresh Start Convenience Stores, Inc. d/b/a Fresh Start
472. FDA-2020-S-0024-02372020-000327 Biogena USA Inc - Vitamin B12 Liquid - Supports healthy nerve cell activity…
473. FDA-2018-E-3184-0006Letter from FDA CDER to U.S. Patent and Trademark Office
474. FDA-2012-N-0110-0003Agency Information Collection Activities; Proposed Collection; Comment Request; Medical…
475. FDA-2022-N-2390-0281Exhibit 145
476. FDA-2024-E-3587-0001Letter from U.S. Patent and Trademark Office to FDA CDER
477. FDA-1976-N-0027-0094Minutes of Meeting February 25, 1985 between FDA/CDER and Industry/Press
478. FDA-1976-N-0027-0078Tab 18 A Comparison of the Central Nervous System Stimulatory Activity of Various…
479. FDA-2012-S-1144-0140NBTY, Inc. (Black Cohosh) - Letter
480. FDA-1980-N-0038-0294Supplement from Center for Drugs and Biologics (CDB) (Vol. 14 of 15)
481. FDA-2003-N-0047-0006Agenda for September 22, 2003 Meeting
482. FDA-2007-D-0369-1084PSG_216718 - Draft Guidance on Omaveloxolone
483. FDA-2024-S-0024-12772024-002167 - Life by Sublime Corp- MULTIPLE CLAIMS (4)
484. FDA-2015-E-0640-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
485. FDA-1993-N-0446-0002Reference 1 Letter from the Board of Tea Experts reference to Standards of Teas for Season…
486. FDA-1976-N-0523-0037Background Material
487. FDA-2019-M-2408-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
488. FDA-2020-P-0698-0001Citizen Petition from Physicians Committee for Responsible Medicine
489. FDA-2007-A-0100-0003FDA Response to Wiley Rein, LLP - Letter
490. FDA-2009-E-0202-0003U.S. Patent and Trademark Office to FDA - Letter
491. FDA-2023-D-2436-0001Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products…
492. FDA-2023-S-0024-00502023-000060 - Reckitt - UpSpring Milkflow orange mango flavored drink mix - Support breast…
493. FDA-2014-N-0189-3140Request for Extension from Anonymous
494. FDA-2004-N-0451-0019Food and Drug Administration Modernization Act of 1997: Modifications to the List of…
495. FDA-2015-H-4791-0001CTP CMP Case re Adel A. Alawdi d/b/a One Star Market
496. FDA-2008-P-0618-0003Philip W. Thomas, P.A. (Patricia Gwen Kiser) to the FDA Division of Dockets Management…
497. FDA-2023-H-2824-0001Complaint
498. FDA-1980-N-0038-0300Reply Motion to Ciba-Geigy from FDA
499. FDA-2023-V-1836-0001Variance Application from Amb Sports & Entertainment
500. FDA-2018-H-1704-0001Complaint
501. FDA-2025-H-3169-0001Complaint
502. FDA-2008-E-0260-0006Determination of Regulatory Review Period for Purposes of Patent Extension; RECOTHROM…
503. FDA-2014-N-0189-8880Request for Extension from Dan C
504. FDA-2010-N-0001-0111Gastroenterology and Urology Devices Panel of Medical Devices Advisory Committee; Notice…
505. FDA-2015-S-0024-2556YBCC Inc - YBCC Tablet Joint N Well - Help to keep joint health
506. FDA-2020-S-0024-08272020-000993 EuroPharma Terry Naturally EuroMedica- Terry Naturally, ViraPro- support a…
507. FDA-2016-D-3548-0002Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for…
508. FDA-1990-G-0246-0101Annex 4 - Testing of the Bio-Catalysat for Living Cells of Protaminobacter Rubrum
509. FDA-2018-H-0381-0001Complaint
510. FDA-2017-H-5399-0001Complaint
511. FDA-2016-H-4254-0001Complaint
512. FDA-1977-N-0025-0055Reference 47: Bidlingmaier, A. et al. "Gastrointestinal Blood Loss Induced by Three…
513. FDA-2016-E-0627-0002Letter from U.S. Patent and Trademark Office
514. FDA-1977-N-0014-1263Answer Letter from FDA/Office of Legislative Services to Honorable Hubert H. Humphrey…
515. FDA-2013-D-1543-0187Nonproprietary Naming of Biological Products; Guidance for Industry; Availability
516. FDA-2018-E-3183-0003Letter from FDA CDER to U.S. Patent and Trademark Office
517. FDA-2017-H-5704-0001Complaint
518. FDA-1987-N-0010-0269Background Material
519. FDA-2016-V-0090-0002Acknowledgement Letter from FDA DDM to Laserglow Technologies
520. FDA-2020-H-0272-0001Complaint
521. FDA-2023-V-5073-0001Variance Application from John Bartlett
522. FDA-2017-N-0084-0008Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse…
523. FDA-2015-P-1553-0010Attachment 9 FDA's Draft Guidance for Industry and Food and Drug Administration Staff…
524. FDA-2014-S-0024-0909NOW Foods (Sytrinol) - Letter
525. FDA-2017-H-2617-0001CMP Complaint Issued to YJK, Inc. d/b/a Jen’s Liquors
526. FDA-2025-H-4098-0001Complaint
527. FDA-2025-P-7433-0004Appendix II
528. FDA-2017-D-0175-0007Reference 4-Merriweather_2015_Produce Related Outbreaks and Illnesses 2011-2014_Memo re…
529. FDA-2004-E-0332-0001USPTO to FDA/CDER - Letter
530. FDA-2015-V-1366-0001Variance Application from Beau Burrows
531. FDA-1998-N-0880-0002Medical Devices; Sunlamp Products Performance Standard; Request for Comments and…
532. FDA-2019-P-3192-0029Letter from FDA CDER to US WorldMeds
533. FDA-2020-P-2212-0050Tab 26 re Citizen Petition from Encore Dermatology Inc
534. FDA-2015-S-0024-1532Nutrition Express - Lindberg® Mag Relax® - Promotes Nerve, Bone and Cardiovascular Health
535. FDA-2024-E-0481-0004Letter from U.S. Patent and Trademark Office to FDA CDER
536. FDA-2022-N-2390-0407Exhibit 86 - Evans (2007)
537. FDA-1992-V-0031-0001Variance Approval Letter from FDA CDRH to Dooley's Incorporated
538. FDA-1980-N-0074-0047Letter from FDA HFD-560 to Jane Baluss-Buc & Beardsley
539. FDA-2023-N-2177-0077Reference 34 - PRIA for LDTs RE: Medical Devices; Laboratory Developed Tests
540. FDA-1975-N-0012-0662Reference 10 Elimination of methicillin-resistant Siaphylococcus aureus from a neonatal…
541. FDA-2022-S-0024-12392022-551- Salus Jaus dist by Gaia Herb MULTIPLE CLAIMS (3)
542. FDA-2009-D-0346-0004Reference 2 - Institute of Food Technologists and FDA. Analysis and Evaluation of…
543. FDA-2025-U-6073-0001Complaint
544. FDA-2015-N-5017-0012Reference 10 - Kerr, L.N., M.P. Chaput, L.D. Cash, et al., Assessment of the Durability of…
545. FDA-1991-N-0365-0297Acknowledgement Letter from FDA DDM to North Penn Anesthesia Institute
546. FDA-2021-N-0471-0279SPRIA References 00_Ag Water Supplemental PRIA Reference List
547. FDA-2020-S-0023-0072NDI 1159 -Title Withdrawn - Reference List
548. FDA-2024-E-0430-0004Letter from U.S. Patent and Trademark Office to FDA CDER
549. FDA-2012-N-0001-0098Endocrinologic and Metabolic Drugs Advisory Committee Meeting
550. FDA-2007-V-0135-0001Acknowledgement Letter to Night Vision System - A DRS Technologies Company
551. FDA-2014-V-1096-0005Variance Approval from FDA CDRH to SOUTH CAROLINA STATE MUSEUM
552. FDA-1977-N-0014-0926Answer Letter from FDA to Comment from The Honorable Melvin Price, United States House of…
553. FDA-2008-M-0608-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
554. FDA-2022-N-2390-0051Letter from FDACDER to Flaxman
555. FDA-2017-H-6953-0001Complaint
556. FDA-2019-H-3852-0001Complaint
557. FDA-2003-P-0174-0034GlaxoSmithKline (GSK) - Correction
558. FDA-2015-S-0024-1323NOW Foods - L-Ornithine - Healthy Protein Metabolism
559. FDA-2015-D-1211-0136Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission…
560. FDA-2018-V-3615-0003Letter from FDA CDRH to SWAROVSKI OPTIK KG
561. FDA-1999-D-0178-0001Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under…
562. FDA-2022-S-0024-06422022-000676- Pharmavite LLC - Nature Made Wellblends Active Immune Defense Powder…
563. FDA-2004-N-0443-0004HFM-340
564. FDA-2016-V-1086-0002Variance Application from Amanda Brucato
565. FDA-2025-H-0289-0001Complaint
566. FDA-2022-N-2390-0234Exhibit 98
567. FDA-2018-H-2002-0001Complaint
568. FDA-1976-N-0031-0169Answer re Request for Extension from Graduate Research Laboratories Inc.
569. FDA-1980-P-0073-0024Laser Fantasy, Inc. - Request for an Amendment
570. FDA-2016-E-2441-0003Letter from FDA CDER to United States Patent and Trademark Office
571. FDA-2007-D-0030-0002Guidance for Industry Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
572. FDA-2012-S-1144-217021st Century HealthCare, Inc. - Coral Calcium 1000 mg over 72 Trace Minerals 120ct capsule…
573. FDA-2004-P-0398-0002HFA-305 to GlaxoSmithKline (GSK)
574. FDA-2014-N-0189-9993Request for Extension from Anonymous
575. FDA-2017-N-0001-0039Science Advisory Board to the National Center for Toxicological Research Advisory…
576. FDA-2003-P-0116-0004HFD-5 to Fish & Richardson and Arnold & Porter
577. FDA-2015-V-2190-0002Acknowledgement Letter from FDA DDM to Illuminati Visual Productions
578. FDA-2016-N-3118-0038redacted_019_TSI Meeting Minutes
579. FDA-2010-S-0664-1734Lifestyle Nutrition, LLC - BOP - Help Your Body Produce Produce Pleasant Tasting and…
580. FDA-2011-S-0932-0606Letter from NBTY, Inc.
581. FDA-2025-V-1155-0001Department of Defense Laser Product Exemption 76EL-01DOD
582. FDA-2024-H-5794-0001Complaint
583. FDA-2015-N-0101-0525Reference 11-296 - FDA-1975-N-0012-0245 --- CP15…
584. FDA-2019-H-3872-0001Complaint
585. FDA-2018-H-3390-0001Complaint
586. FDA-2023-N-3902-1342Comment from Katherine Dockter
587. FDA-2023-N-5451-0004Agency Information Collection Activities; Announcement of Office of Management and Budget…
588. FDA-2023-N-3902-1528Comment from Anne Marie Brostrup-Jensen
589. FDA-2024-H-5243-0001Complaint
590. FDA-2025-P-5435-0001Citizen Petition from Chul-Hi Park
591. FDA-2014-V-2052-0002Acknowledgement Letter From FDA DDM to SLD Lighting
592. FDA-2017-H-1536-0001CMP Complaint Issued to Art’s Liquor Shoppe, Inc. d/b/a Art’s Liquor – Fine Wine
593. FDA-2014-N-0189-83085Reference 181 Effects of Duration of Electronic Cigarette Use re Deeming Tobacco Products…
594. FDA-2021-V-0871-0004Variance Amendment from Laser Encore
595. FDA-2025-H-2082-0001Complaint
596. FDA-1993-F-0116-0003Environmental Assessment from National Aeronautics and Space Administration (NASA)
597. FDA-1997-P-0024-0001Medical Devices; Reclassification and Codification of Fully Automated Short- Term…
598. FDA-2012-S-1144-2240Perrigo - TopCare - Fish Oil - Omega-3 fatty acids, EPA and DHA, help support heart…
599. FDA-2021-N-0175-0001Virtual Public Meeting: FDA Rare Disease Day 2021
600. FDA-2023-P-4552-0002Acknowledgment Letter from FDA DMS to Nines Consult Pharma, LLC
601. FDA-2016-H-0342-0001CTP CMP Case re Bob Brandi Stations, Inc. d/b/a Pitt Stop 32
602. FDA-2004-Q-0427-0049Fleminger, Inc. - Letter
603. FDA-2020-V-2250-0003Variance Withdrawal Letter from FDA CDRH to Cinionic Inc.
604. FDA-2014-N-1209-0009Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the…
605. FDA-1985-N-0006-0003FDA
606. FDA-2016-S-0024-1723iHealth Inc - Estroven Maximum Strength + Energy - Helps manage mood
607. FDA-1997-S-0006-0508HFS-456 to The Winning Combination - Letter - Let 217
608. FDA-2010-S-0664-2513Cytosport, Inc. - Monster Mass - Increase Lean Muscle Mass
609. FDA-2019-H-2947-0001Complaint
610. FDA-2019-D-1876-0001Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for…
611. FDA-2019-H-5938-0001Complaint
612. FDA-2019-S-0024-05222019-1472 NexgenPharma- MULTIPLE (34)
613. FDA-2002-N-0100-0001Bavarian Red Cross; Revocation of U.S. License No. 1002
614. FDA-2006-P-0391-0012Citizen Petition Approval from FDA CDER to Orchid Healthcare
615. FDA-2020-V-2069-0001Variance Application from Midwest Computer Products
616. FDA-2022-S-0024-06362022-000667 - Lang Pharma Nutrition Inc. - Walmart Equate Prostate Health Beta Plus…
617. FDA-2021-V-0281-0001Variance Application from Next Audio Video
618. FDA-2021-N-0127-0019Panel-6-FDA-Stewart-and-Merchant-Slides-508
619. FDA-2005-N-0295-0002Agenda - "Assessing Consumer Perceptions of Health Claims, November 17, 2005" - Public…
620. FDA-2022-V-0421-0003Variance Approval from FDA CDRH to Tyler Olson
621. FDA-2018-H-0653-0001Complaint
622. FDA-2024-D-2604-0025Reference 22 - FDA. Warning letter to J.M. Smucker LLC. (January 23, 2023). Available at…
623. FDA-2019-H-2346-0001Complaint
624. FDA-1978-N-0021-0017Acknowledgment letter from FDA/CDER to C.I.B.A. Consumer Pharmaceuticals
625. FDA-2025-V-0594-0002Acknowledgment Letter from FDA DMB to Beau Dyvig
626. FDA-2016-M-1754-0001Premarket Approval Response from FDA CDRH to Aspire Bariatrics, Inc., Aspire Assist
627. FDA-2004-E-0267-0002HFD-005 to U.S. Patent & Trademark Office
628. FDA-2015-S-0024-1329Pro Caps Laboratories - World Health - Promote urinary tract health
629. FDA-1980-N-0015-0011Bacterial Vaccines & Toxoids Implementation of Efficacy Review-Proposal
630. FDA-2018-S-0024-02522018001420 - Harmony Foods - Spring Valley Melatonin + Botanicals - Sleep Support
631. FDA-2019-E-3166-0005Determination of Regulatory Review Period for Purposes of Patent Extension; ELZONRIS
632. FDA-2024-P-5470-0002Acknowledgment Letter from FDA DMB to Novitium Pharma LLC
633. FDA-2022-V-2886-0001Variance Application from Kratos Productions
634. FDA-2015-S-0024-3543Perrigo Company of South Carolina - Kroger®- One Daily - Suppport Heart Health, Normal…
635. FDA-1977-N-0002-0663Envelope re: Comment from the Honorable Senator Hubert H. Humphrey
636. FDA-1977-N-0002-0860Envelope re: Comment from Honorable Dale Bumpers, United States Senate
637. FDA-2009-S-0607-1047Advanced Orthomolecular Research, Inc. - CureCumin - Enhances the Immune System
638. FDA-2011-E-0113-0007FDA\CDER to United States Patent and Trademark Office - Letter
639. FDA-2021-V-1167-0001Variance Application from Mario Antonetti
640. FDA-2020-P-1575-0004Interim response letter from FDA CDER to Francis E. O'Donnell
641. FDA-1980-N-0038-0632EXHIBIT G-2.3 - Patient report forms from Carpenter Study
642. FDA-2019-H-0718-0001Complaint
643. FDA-2023-H-1269-0001Complaint
644. FDA-2015-P-3794-0001Citizen Petition From Lawrence R. Savage
645. FDA-2017-P-1252-0002Acknowledgement Letter from FDA DDM to Xiromed LLC on behalf of LifePharma FZE
646. FDA-2019-H-3724-0001Complaint
647. FDA-2023-H-0882-0001Complaint
648. FDA-2013-E-0681-0008Letter from FDA CDER to the U.S. Patent and Trademark Office
649. FDA-2025-H-4592-0001Complaint
650. FDA-2022-H-3271-0001Complaint
651. FDA-2014-N-1051-0449448 7694105 RDC CRF Subject R4008_Redacted
652. FDA-2019-D-2966-0025Male Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability
653. FDA-2017-H-6298-0001Complaint
654. FDA-2017-H-0492-0001CTP CMP Complaint from FDA CTP to Shiv Shiv Om Inc. d/b/a Market Square Liquors
655. FDA-1987-V-0013-0009Reporting Guide for Laser Light Shows and Displays from Benedum Natural Science Theater
656. FDA-2016-H-4125-0001Complaint
657. FDA-2016-N-3118-0295168_FDA Study Data
658. FDA-2023-H-2356-0001Complaint
659. FDA-2002-M-0116-0001Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
660. FDA-1997-S-0039-0753LANE LASS USA, Inc. - Letter
661. FDA-2007-D-0369-0554Product-Specific Guidance for Cilastatin Sodium; Imipenem; Relebactam; Draft Guidance for…
662. FDA-2014-P-0282-0002Acknowledgement Letter From FDA/DDM to Custo Pharm, Inc.
663. FDA-2007-N-0199-0009Piazza-Hepp, Toni
664. FDA-2005-V-0278-0003Patrick AFB Rocket Lanes - Approval for Variance
665. FDA-1995-S-0036-0171Annual Report from ProTECT III Emory University School of Medicine Public Disclosure IND…
666. FDA-2019-S-0024-10092019-002804 -Nutranext LLC - Natural Vitality, Calm Magnesium Glycinate Capsule - Supports…
667. FDA-2004-N-0057-0041National Conference of State Legislatures
668. FDA-2016-N-3120-05080000_M5_5311bioavailiabilty_bioequivalence
669. FDA-1977-N-0002-1143Answer Letter from FDA/Office of Legislative Services to Honorable Bill Proxmire, United…
670. FDA-2016-S-0024-1212Prestige Blending PTY LTD - International Protein- Protein Synergy 5 - Slightly more…
671. FDA-2025-P-6074-0002Acknowledgement Letter from FDA DMB to Diamond Research Foundation
672. FDA-2015-E-1685-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
673. FDA-2022-D-0053-0002Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption…
674. FDA-1982-N-0009-0003FDA/DDM
675. FDA-2017-V-3167-0001Variance Application from Invisible Entertainment
676. FDA-2017-R-6143-0001NTSO Complaint
677. FDA-2008-D-0339-0018Guidance for Industry; Updating Labeling for Susceptibility Test Information in Systemic…
678. FDA-2011-V-0670-0001Broken Arrow Roller Sports - Application for Variance
679. FDA-2016-N-3389-0109Reference 02-105 Inulin decreases short-term markers of colonic fermentation similarly in…
680. FDA-2023-S-0024-05212023-001054 - Madison One Acme Inc. - Yulam, Niuhuang Qingxin Wan Herbal Supplement…
681. FDA-2017-N-5056-00012017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public…
682. FDA-2013-N-1524-1938Nomination Letter Folic Acid USP re: Comment from Fagron
683. FDA-1987-N-0010-0129Background Material
684. FDA-2019-S-0024-07182019002545-NOW Foods- NOW Foods Iron Complex Caps - Supports iron absorption and…
685. FDA-2013-V-0661-0001Good Tyme Rock N Roll - Application for Variance
686. FDA-2011-N-0002-0122National Mammography Quality Assurance Advisory Committee Notice of Meeting
687. FDA-2019-D-4015-0001Final Guidance - The Abbreviated 510(k) Program
688. FDA-2016-S-0024-1932Nutrition Express - Lindberg® Cayenne 500 mg - Supports Vascular and Digestive Health
689. FDA-2018-N-1095-0002Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
690. FDA-2001-M-0182-0001Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
691. FDA-2023-N-3976-0001Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program; Program…
692. FDA-2018-H-3927-0001Complaint
693. FDA-2015-S-0024-3217Country Life - Country Life/ Power-dophilus® Dairy Free Probiotic - Supports digestive…
694. FDA-2024-H-0579-0001Complaint
695. FDA-1978-N-0011-0004Antiperspirant Drug Products for Over-The-Counter Human Use Establishment of A Monograph…
696. FDA-1992-N-0004-0002Letter from FDA to Juan Manuel Rodgriguez
697. FDA-2011-N-0921-19026QAR _Reference 201_Taylor-2010-Short Communications, Salmonella infections in garden birds…
698. FDA-2018-P-2040-0004Exhibit 2-Proposed Package Insert for Atropine Sulfate Injection, 1.0 mg/mL (1 mL Single…
699. FDA-1997-C-0051-0002Listing of Color Additives Exempt from Certification; Phaffia Yeast; Confirmation of…
700. FDA-2003-P-0184-0001Acknowledgment Letter from FDA DMB to Russel J. Thomsen, M.D.
701. FDA-2024-N-5471-0571Reference 569 Shah Smoking and stroke the more you 2010
702. FDA-2024-N-5933-0054018482_Approval_Pkg_Procardia
703. FDA-1976-N-0525-0031Procedures for Investigational Device Exemptions - Notice of Correction
704. FDA-2015-S-0024-2253NBTY, Inc. - Flaxseed Oil - Supports heart and cardiovascular health
705. FDA-2025-H-6486-0001Complaint
706. FDA-2016-E-1282-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
707. FDA-2011-V-0927-0003FDA/CDRH to Audio Integration Services - Approval for Variance
708. FDA-2013-N-0578-0003Agency Information Collection Activities; Announcement of Office of Management and Budget…
709. FDA-2016-N-1111-1747Reference 4 - Panel Meeting Roster re Banned Devices; Electrical Stimulation Devices for…
710. FDA-2019-H-1691-0001Complaint
711. FDA-1999-D-0062-0003Draft Guidances for Industry on Food-Contact Substance Notification System; Availability
712. FDA-1975-N-0017-0021Acknowledgment Letter from FDA/DDM to Pharmaton Ltd.
713. FDA-2013-N-0013-0170Agenda and Roster from the February 27, 2014 Public Meeting on FSMA Proposed Rules on…
714. FDA-2013-N-1524-2036Nomination Letter Melatonin re: Comment from Fagron
715. FDA-2007-N-0322-0002Science Board to the Food and Drug Administration; Notice of Meeting
716. FDA-2024-S-0024-10112024-001889 - Swanson Health Products (11658148874) - Swanson Health Product, Akkermansia…
717. FDA-2017-D-2163-0001Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for…
718. FDA-1982-N-0011-0002FDA
719. FDA-2011-V-0749-0002Acknowledgement Letter to Anacaona
720. FDA-2025-V-1022-0001Variance Request from Connect Services, Inc
721. FDA-2019-V-4154-0005Variance Approval Letter from FDA CDRH to Introspective Productions, LLC
722. FDA-2012-N-1210-1006Reference 76 Usual Intake of Energy from Added Sugars re Food Labeling: Revision of the…
723. FDA-2013-D-0286-0013Agency Information Collection Activities; Announcement of Office of Management and Budget…
724. FDA-2009-E-0400-0001U.S. Patent & Trademark Office to FDA/CDER - Letter
725. FDA-1997-N-0066-0003Notice of Final Rule re Revision to the General Safety Requirements for Biological…
726. FDA-2022-S-0024-00282022-000004 - Anewcare International Inc - Joint Free - Helps promote joint comfort
727. FDA-1990-N-0007-0101Background Material
728. FDA-2017-H-4471-0001CMP Complaint Issued to Bueno Grocery Inc. d/b/a Bueno Grocery
729. FDA-1977-N-0014-0833Answer Letter from FDA to Comment from The Honorable Eldon Rudd, United States House of…
730. FDA-2024-V-1492-0003Variance Approval Letter from FDA CDRH to Orbital Productions LLC
731. FDA-2015-S-0024-0675Perrigo Company - Meijer™ - Promotional - Meijer Cranberry may help support urinary tract…
732. FDA-1990-N-0007-0015Comments of The Center for Science in the Public Interest Reference 95 - Background…
733. FDA-1997-S-0039-1664Letter from Perrigo Company of South Carolina - Memory Support
734. FDA-2015-S-0024-0633NBTY, Inc. - Biotin - Supports healthy hair, skin and nails
735. FDA-2018-H-2179-0001Complaint
736. FDA-2019-P-2124-0002Acknowledgment Letter from FDA DDM to C Laser Inc.
737. FDA-2014-N-0189-42522Request for Extension from Matthew Langelier
738. FDA-2024-P-5807-0004Interim Response Letter from FDA CDER to Douglas R. Smith
739. FDA-2021-S-0024-04262021-000641 EuroPharma Terry Naturally EuroMedica - Terry Naturally, Menopause ReliefPlus…
740. FDA-2008-P-0616-0003FDA to Foley & Lardner, LLP on behalf of Pusher-Smith Laboratories, Inc. - Petition Denial
741. FDA-2010-S-0664-0796Hyalogic LLC - Myodurance - Supports Power Output and Normal Muscle Recovery
742. FDA-2018-P-4664-0004Withdrawal from Fresenius Kabi USA LLC
743. FDA-2017-S-0023-0021NDI 984 - Superior Hemp Oil from HoneyColony
744. FDA-2014-E-2357-0004Letter from FDA CDER to the U.S. Patent and Trademark Office
745. FDA-2024-H-5034-0001Complaint
746. FDA-2023-H-2161-0001Complaint
747. FDA-2022-H-3250-0001Complaint
748. FDA-2022-N-2390-0503Exhibit 186 - Belsomra Stat. Rev.
749. FDA-2021-V-0060-0003Variance Approval from FDA CDRH to Melodrip Co., LLC
750. FDA-2023-H-4115-0002Amended Complaint
751. FDA-2023-H-0274-0001Complaint
752. FDA-2009-P-0318-0001Strides Arcolab Ltd - Citizen Petition
753. FDA-2022-V-0037-0001Variance Application from Nelsound
754. FDA-2024-S-0024-04932024-001318 - Comfort Click Limited - WeightWorld, Multivitamin-120 Gummies- SUPPORTS…
755. FDA-2025-P-6763-0002Acknowledgment Letter from FDA DMB to University of Illinois, College of Pharmacy
756. FDA-2015-N-3469-0314Nomination from Outsourcing Facilities Association
757. FDA-2007-D-0369-0637Draft Guidance on Ketoprofen - PSG_018754
758. FDA-2017-P-6411-0001Citizen Petition from Insys Therapeutics, Inc.
759. FDA-2025-H-0905-0001Complaint
760. FDA-2023-H-2326-0001Complaint
761. FDA-2014-N-0189-6319Request for Extension from Anonymous
762. FDA-2025-S-0023-0013NDI 1376 - S-Adenosyl-L-Methionine Disulfate Tosylate (SAMe-DT) from Shandong Jincheng…
763. FDA-2023-H-2375-0001Complaint
764. FDA-2009-N-0435-0002Current Good Manufacturing Practice Requirements for Combination Products; Correction
765. FDA-1996-N-0028-0145Pre_FDMS - OMB Review 10/25/2005
766. FDA-2017-P-2674-0006ATTACHMENT 4 - NDA APPROVAL re Request that the FDA declare that Empagliflozin and…
767. FDA-2018-P-0877-0004Memo of correspondence with The Food Lawyers on Konjac Flour Citizen Petition
768. FDA-1984-N-0259-0032Exhibit G-3.25 re: Disclosure of Data and Information from Center for Drugs and Biologics…
769. FDA-2024-S-0024-09742024-001849 - SVC Labs Ltd - STYRKR MIX90 Dual-Carb Drink Mix- SUPPORTS ENERGY
770. FDA-1995-N-0054-13938Background Information to NPR1
771. FDA-2014-D-0447-0016Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About…
772. FDA-2023-V-5066-0001Variance Application from Grid Lasers, LLC
773. FDA-1984-G-0007-0097Background Material: Hazleton Laboratories America, Inc.
774. FDA-2014-N-1051-0512511 7694105 RDC CRF Subject R4071_Redacted
775. FDA-2012-P-0747-0002Acknowledgement Letter to Leroy Leslie Hamilton, Ph.D.
776. FDA-2011-S-0932-0696NBTY, Inc. (Healthy Accents Ginkgo Biloba Supplements)
777. FDA-2019-E-3293-0002Patent Extension Application from Wenderoth Lind & Ponack LLP (on behalf of Shionogi &…
778. FDA-1993-G-0218-0129Section 2/Subsection A of Reference A-2 - Average Composition and Digestible Nutrients re…
779. FDA-1984-N-0259-0527Exhibit G-7.21 re: Disclosure of Data and Information from Center for Drugs and Biologics
780. FDA-2014-D-0055-0555Reference 40 - PHE_salt_reduction_targets_2024 re Voluntary Sodium Reduction Goals: Target…
781. FDA-1978-N-0716-0021Tab 20 Proposed American Institute of Ultrasound in Medicine Nomenclature, Fifth Draft…
782. FDA-2013-N-0227-0094Reference 26 RJR ACD Nonconformance Report Corrective Action Request Form 2007
783. FDA-1978-N-0622-0006Classification of Calibrators for Red Cell and White Cell Counting
784. FDA-2014-E-0943-0006Determination of Regulatory Review Period for Purposes of Patent Extension; TECFIDERA
785. FDA-2013-V-0599-0001R Squared and Sound Custom Speakers - Application for Variance
786. FDA-2009-S-0607-1570Perrigo - CareOne® - Papaya Enzyme - Digestive Flealth
787. FDA-2024-N-5338-0005Agency Information Collection Activities; Announcement of Office of Management and Budget…
788. FDA-1996-N-0028-0280See FDA-1996-N-0028-0673
789. FDA-1997-S-0039-1236Nature's Answer - Inflama-Dyne Capsules - PROMOTES: Joint Comfort, Mobility & flexibility…
790. FDA-2013-D-0501-0004Center for Devices and Radiological Health Appeals Processes: Questions and Answers About…
791. FDA-2015-S-0024-0824USANA Health Sciences, Inc. - Vitamin D - A fat-soluble vitamin that supports cellular…
792. FDA-2019-E-3051-0002Letter from U.S. Patent and Trademark Office to FDA CDER
793. FDA-2007-D-0369-2205PSG_208843 - Draft Guidance on Hydroxyurea
794. FDA-2011-N-0002-0028Public Workshops: Clinical Trial Requirements, Regulations, Compliance, and Good Clinical…
795. FDA-2002-P-0208-0002Enclosure from FDA CFSAN to Food Analysis and Diagnostic Laboratory
796. FDA-1992-P-0065-0005Interim Response Letter from FDA/CDER to Washington Legal Foundation
797. FDA-2002-P-0297-0001FDA/DDM to Highland VetPharma, LLC
798. FDA-2016-E-0627-0001Patent Extension Application from Morrison & Foerster LLP (on behalf of Cerus Corporation)
799. FDA-2016-H-3776-0001Complaint
800. FDA-2022-S-0024-12342022-1278- Contract Pharmacal Corp- PXL PLAY- RELAX- PROVIDES COGNITIVE SUPPORT
801. FDA-1976-N-0525-0138American Society for Microbiology - Appearance Request
802. FDA-2024-E-0431-0003Letter from FDA CDER to U.S. Patent and Trademark Office
803. FDA-2017-N-6189-0096Reference 129_Har_Monthly Project Development Report
804. FDA-2017-P-2659-0006Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From…
805. FDA-2018-H-3507-0001Complaint
806. FDA-2019-H-1462-0001Complaint
807. FDA-2011-N-0003-0046Enviromental Risk Assessment NADA 141-064
808. FDA-2006-M-0122-0001FDA
809. FDA-2003-P-0351-0017Attachment 8 - "Excerpt from Report of Clinical Study (Feb. 1,200l) Protocol 0600D…
810. FDA-2023-H-3789-0001Complaint
811. FDA-1997-S-0039-1411Pacific Health Laboratories, Inc - Endurox Excel Antioxidant Regenerator - proven to…
812. FDA-2014-H-0835-0001Complaint
813. FDA-2015-V-1654-0002Acknowledgement Letter From FDA DDM to Zachary Bryla
814. FDA-2021-S-0024-05632021-000884 - Nutranext- Rainbow Light, ProbioActive (90 Capsules)- promote gut and immune…
815. FDA-2017-P-5787-0135Reference 133 Payne_Formation of DHT in Human Testis (JCEM 1973) re Citizen Petition Post…
816. FDA-2002-N-0153-0011Tab 4 - [J. Bradley Brown "Multiple Telephone Conversations Between August 26th &…
817. FDA-2007-N-0442-0078Transcript - FDA – Standards for Pet Food and other Animal Feed
818. FDA-2004-D-0119-0001FDA
819. FDA-2017-H-0645-0001CMP Complaint Issued to Mugali Yafay d/b/a Gold Star Mini Mart
820. FDA-2014-S-0024-0854Perrigo Company (Meijer - Vitamin B complex) - Letter
821. FDA-2011-F-0172-0547OMB Executive Order 12866 Regulatory Planning and Review re Food Labeling; Nutrition…
822. FDA-1990-N-0007-0094Background Material
823. FDA-2015-S-0024-2974Perrigo - Equate - promotional - Equate Krill Oil contains Omega-3 fatty acids that help…
824. FDA-2015-N-2372-0001Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for…
825. FDA-2018-M-1791-0001P170035 approval package - Bausch + Lomb, Inc. Bausch + Lomb ULTRA (samfilcon A) Contact…
826. FDA-2018-H-3173-0001Complaint
827. FDA-2007-N-0376-0005FDA
828. FDA-2011-D-0376-1917Request to Extend Comment Period from Henry Mouton
829. FDA-2020-N-2029-0107DP 3 2019-04-07 Dr. O Brien Letter
830. FDA-2009-P-0223-0001Mutual Pharmaceutical Company, Inc. - Citizen Petition
831. FDA-2016-N-3120-0483Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate…
832. FDA-1997-S-0039-0976Letter from Perrigo Company of South Carolina
833. FDA-2018-N-4626-0111Nomination from Wedgewood Pharmacy
834. FDA-2023-H-1151-0001Complaint
835. FDA-2025-N-0349-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
836. FDA-2015-E-3439-0006Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIO
837. FDA-2007-N-0440-0001Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing…
838. FDA-2009-S-0607-1630Perrigo Company of South Carolina - CareOne®-CoQ-10 & Fish Oil - Ultimate Heart Health…
839. FDA-2022-S-0024-11652022-001269 - TSI USA LLC - Tailored Script, Olive leaf - Supports immune system
840. FDA-2021-V-1267-0001Variance Application from Garrett Mcgrath
841. FDA-2015-N-0101-0376Reference 11-149 - FDA-1975-N-0012-0187 --- CP8…
842. FDA-2017-H-0422-0001Complaint from FDA CTP to Eric Ramirez Rodriguez d/b/a Texaco Parguera Service Station /…
843. FDA-2003-N-0301-0001FDA
844. FDA-2025-P-6089-0024Reference 22 - The effect of haptens on protein-carrier immunogenicity - PMC
845. FDA-2022-P-0695-0001Citizen Petition from Ronald Brock
846. FDA-2022-H-1254-0001Complaint
847. FDA-2018-D-3583-0001Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry…
848. FDA-1981-N-0083-0088FDA Phone Conversation between Dr. Robert Shapiro and Dr. Alfred Milbert
849. FDA-2025-P-1373-0007Amendment to Suitability Petition from Senores Pharmaceuticals, Inc.
850. FDA-2023-P-4334-0003Attachment 1 - Orange Book: Approved Drug Products with Therapeutic Equivalence…
851. FDA-1977-N-0030-0001FDA
852. FDA-2010-P-0111-0014Acknowledgement to Shire Pharmaceuticals, Inc. - Correction
853. FDA-2008-V-0089-0002Acknowledgement Letter to Fullhouse Production LLC
854. FDA-2010-M-0135-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
855. FDA-2015-H-3502-0001CTP CMP Case re Main and Mason, LLC d/b/a Pick ‘N Roll / Main Street BP
856. FDA-2011-D-0125-0015Guidance for Industry: Establishing That a Tobacco Product Was Commercially Marketed in…
857. FDA-2025-P-7372-0002Acknowledgement Letter from FDA DMB to Elry Hei
858. FDA-2012-D-0049-0035Agency Information Collection Activities; Submission for Office of Management and Budget…
859. FDA-2007-P-0346-0076Supplement from Dr. Richard Sauerheber, Palomar College
860. FDA-2011-S-0932-0907NBTY, Inc. (H-E-B Vitamin C with Rose Hips Supplements)
861. FDA-1977-N-0002-1031Answer Letter from FDA to Comment from the Honorable Clifford P. Case, United States…
862. FDA-2012-E-1230-0001Discovery Laboratories, Inc. (Dechert, LLP) - Patent Extension Application
863. FDA-2013-N-0568-0001Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
864. FDA-2012-M-0390-0002Safety and Effectiveness Summaries for Premarket Approval Applications; Availability…
865. FDA-2020-M-2118-0001Premarket Approval for P200026 – Medtronic Vascular, Inc Abre Venous Self-expanding Stent…
866. FDA-2016-N-0124-037516-5-2-coas-of-reference-standards
867. FDA-2024-H-3347-0001Complaint
868. FDA-1998-P-1154-0001Citizen Petition from Protein Technologies International Inc
869. FDA-2017-H-0202-0001Complaint from FDA CTP to Cuatro “A” Food Market, Inc. d/b/a Supermercados Fam Coop
870. FDA-2015-S-0023-0020NDI 859 - Ceratonia siliqua L. - Original NDI Notification
871. FDA-2019-N-4060-0014Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances…
872. FDA-2005-N-0294-0006HFA-305 to the International Association Color Manufacturers
873. FDA-2016-P-0383-0004Petition Denial Letter Final Response
874. FDA-2019-H-3364-0001Complaint
875. FDA-2022-N-3122-0045CVM Virtual Public Meeting: FDA and the AAFCO Animal Feed Ingredient Definition Process…
876. FDA-2013-S-0024-008521st Century HealthCare Inc - Black Cohosh & Soy Isoflavones vegetarian capsules 60ct…
877. FDA-2021-S-0024-14192021-3562 GNC Live Well - MULTIPLE CLAIMS (15)
878. FDA-2023-H-1257-0001Complaint
879. FDA-1999-N-0134-0040Risk Assessment
880. FDA-2008-C-0098-0005Memorandum from A. Khan, Division of Petition Review, to F. Ellison Divison of Petition…
881. FDA-2024-S-0024-00822024-000396 - Sports Research - Supports Healthy Hair
882. FDA-2022-V-1214-0001Variance Application from Lucas Jensen
883. FDA-2024-V-0259-0003Variance Approval Letter from FDA CDRH to SAMSAT, aka The San Antonio Museum of Science…
884. FDA-2009-E-0231-0001U.S. Patent & Trademark Office to FDA/CDER - Letter
885. FDA-2014-N-0189-10134Request for Extension from Anonymous
886. FDA-2017-H-6464-0001Complaint
887. FDA-2018-D-3197-000403 Reference 1 - Lookback for HCV Guidance
888. FDA-2011-S-0932-1219NBTY, Inc. - Chewable Acidophilus - Promotes Immune & Digestive Health
889. FDA-2015-S-0024-1622Mountain Rose Herbs - Mountain Rose Herbs, Kava Kava Extract - Promotes relaxation and…
890. FDA-1984-N-0259-0225Exhibit M-92, M-94, M-96, M-97, M-98, M-100, M-101, M-102, M-103, M-104, M-105, M-106 re…
891. FDA-2012-N-0564-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Dietary…
892. FDA-2019-H-5746-0001Complaint
893. FDA-2003-V-0237-0002HFA-305 to Area 54 DJ Co.
894. FDA-2010-N-0002-0034Norocillin Penicillin G Procaine Injectable Suspension (NADA 065-010) - Freedom of…
895. FDA-1979-N-0028-0006Permanent Listing of Color Additive Lakes - Part 3 of 3; Pages 200-225 - Notice of…
896. FDA-2009-S-0607-0692FoodScience Corporation - Mito-Fuel - Support Workout Recovery
897. FDA-2023-D-0026-0001Patient-Focused Drug Development: Incorporating Clinical OutcomeAssessments Into Endpoints…
898. FDA-2014-N-1051-0856Reference 11 MMWR 2011 60 re Modified Risk Tobacco Product Applications: Applications for…
899. FDA-1996-G-0243-0001Roquette America, Inc., and American Maize-Products Co., Filing of a Petition for…
900. FDA-2017-H-1523-0001CMP Complaint Issued to Stewart Calvin Jr. and Kim D. d/b/a We Got It
901. FDA-2024-S-0024-13182024-002209 - Iovate Health Sciences International Inc.- Six Star Pre-Workout Explosion…
902. FDA-1977-N-0016-0013FDA/Office of Legislative Services to G. William Whitehurst - Answer5
903. FDA-2015-H-0468-0001Complaint
904. FDA-2014-H-0592-0001Complaint
905. FDA-2025-S-0024-09582025-001037 - Pharmavite LLC - Nature Made B-Complex Gummies - ENERGY + BRAIN
906. FDA-2016-D-2565-0030Draft Guidance for Industry and FDA_510(k) Third Party Review Program and Third Party EUA…
907. FDA-1991-E-0018-0005Letter from FDA Office of Health Affairs to the U.S. Patent and Trademark Office
908. FDA-2006-P-0085-0001Acknowledgment Letter from FDA DMB to Sicor Pharmaceuticals, Inc.
909. FDA-2009-N-0592-0003Reference 2 - "World Medical Association Declaration of Helsinki Ethical Principles for…
910. FDA-2017-E-6701-0002Letter from U.S. Patent and Trademark Office
911. FDA-1982-P-0018-0236Background Material
912. FDA-2011-N-0599-0041Letter from Allergy Laboratories, Inc to FDA CBER
913. FDA-2019-H-5520-0001Complaint
914. FDA-2018-N-1111-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent…
915. FDA-2011-P-0460-0001Citizen Petition fromLachman Consultant Services, Inc.
916. FDA-2023-H-1912-0001Complaint
917. FDA-1997-S-0039-1534Horizon Nutraceuticals - MSM Joint Response - Provides three of the most important…
918. FDA-2023-S-0024-00242023-000029 - Blueroot Health- Fairhaven Health, PregEase- Supports healthy gut function…
919. FDA-1977-N-0014-0937Answer Letter from FDA to Comment from The Honorable Harrison A. Williams, Jr., United…
920. FDA-2013-E-0780-0005Determination of Regulatory Review Period for Purposes of Patent Extension; VASCEPA
921. FDA-2013-M-0205-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
922. FDA-2008-P-0618-0013Patricia Gwen Kiser [Philip W. Thomas, P.A.] - Supplement
923. FDA-2024-H-2747-0001Complaint
924. FDA-2011-N-0921-18832QAR _Reference 7_Bagcigil-2007-Fecal Shedding of Salmonella spp in Dogs-J VET MED SCI re…
925. FDA-2011-S-0932-1557Organic India, U.S.A. - Organic India Shatavari - Provides Natural Phytoestrogens
926. FDA-2017-P-4249-0004Attachment 2 Dotarem approved label re Suitability Petition from GE Healthcare Inc
927. FDA-2019-H-1520-0001Complaint
928. FDA-2003-D-0030-0001FDA
929. FDA-2023-H-3209-0001Complaint
930. FDA-1997-S-0039-2236Enzymatic Therapy, Inc. - BP Manager - Lycopene is a major nutrient for support of…
931. FDA-2023-E-3196-0005Letter from FDA CDER to U.S. Patent and Trademark Office
932. FDA-2011-N-0003-0010Freedom Of Information Summary - 200-026 [PENNOX 343]
933. FDA-2003-D-0089-0059Background Material
934. FDA-2023-H-3597-0001Complaint
935. FDA-2014-N-0189-10294Request for Extension from Anonymous
936. FDA-2013-S-0024-1029NBTY - Vitamin B-12 - Nervous System Support
937. FDA-2008-E-0551-0003USPTO to FDA/CDER - Letter
938. FDA-2022-V-0438-0003Variance Approval Letter from FDA CDRH to Maurice Foy
939. FDA-2020-E-1817-0003Letter to U S Patent and Trademark Office
940. FDA-2018-N-4626-1043Nomination from Wedgewood Pharmacy
941. FDA-2023-H-5285-0001Complaint
942. FDA-2021-P-0137-0001Suitability Petition from Hyman, Phelps & McNamara, P.C.
943. FDA-2011-S-0932-2760Maximum Human Performance, LLC - Dark Matter - Post Workout Muscle Growth Accelerator
944. FDA-2013-N-0227-0148Reference 80 USGAO Report No GAO 03 485 Pesticides on Tobacco 2003
945. FDA-2014-F-0988-0004BASF Corp.; Filing of Food Additive Petition (Animal Use)
946. FDA-2021-S-0024-01572021-000182 Orgain - Orgain, Immune Support - promotes daily wellness and supports immune…
947. FDA-2016-H-3214-0001Complaint
948. FDA-2020-N-1307-0001Agency Information Collection Activities; Proposed Collection; Comment Request…
949. FDA-2020-S-0024-09162020-001096 LifeVantage- Protandim NRF1 Synergizer- Supports mitochondria production and…
950. FDA-1999-E-0148-0001Letter from FDA/CDER to US Patent and Trademark Office
951. FDA-2004-E-0143-0004FDA
952. FDA-2022-N-0198-0003Response Letter from FDA ORA to Mark Moffett
953. FDA-2011-S-0932-1741Dee Cee Laboratories, Inc. - #765 Vitamin D 2000 IU - Essential for Strong Bones and Teeth
954. FDA-2010-S-0664-1012Vitacost.com, Inc. - NSI L-Theanine From Suntheanine - Nutures Greater Mental Focus
955. FDA-2023-H-1436-0001Complaint
956. FDA-2023-H-4813-0001Complaint
957. FDA-2020-S-0024-03312020-000437 Rajputana Agrico- MULTIPLE CLAIMS (10)
958. FDA-2014-N-1051-0271270 7694105 Diary Subject R4112_Redacted
959. FDA-2024-H-1122-0001Complaint
960. FDA-2014-N-0189-8290Request for Extension from Anonymous
961. FDA-1993-P-0169-0003Interim Response Letter from FDA CDER to Scott G. Beach Redacted
962. FDA-2023-S-0024-00482023-000061 - Luvolux Inc - SUKU Vitamins, Mega Magnesium - Supports bone, teeth, and…
963. FDA-2011-E-0141-0006Determination of Regulatory Review Period for Purposes of Patent Extension: LASTACAFT
964. FDA-2006-V-0096-0004Universal Studios Florida - Application for Variance
965. FDA-2023-S-0024-04402023-000920 - L-Nutra Inc.- L-Pill Dietary Supplement- Supports Healthy Aging
966. FDA-2012-P-0993-0002Acknowledgement Letter to Sheppard, Mullin, Richter & Hampton, LLP
967. FDA-2017-H-2534-0001CMP Complaint Issued to A and B Fast Fill LLC, d/b/a Fast Fill / Shell
968. FDA-2006-P-0325-0004Letter from FDA CBER to Vaccine For All LLC
969. FDA-2003-E-0262-0006U.S. Patent and Trademark Office to Pharmacia Corporation
970. FDA-2008-S-0663-0025Kura Natural, Inc. Megrelian Valerian Valerian officinalis extract , menthol oil…
971. FDA-2024-H-5856-0001Complaint
972. FDA-2020-H-0534-0001Complaint
973. FDA-2007-D-0369-2099Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry…
974. FDA-2013-V-1284-0004Variance Application Renewal from Any Excuse for a Party Inc.
975. FDA-2006-N-0237-0043Request for Extension from Pendergast Consulting
976. FDA-2011-N-0002-0007Industry Exchange Workshop on Drug and Device Requirements; Public Workshop
977. FDA-2025-V-0205-0001Variance Application from Thomas Hoole
978. FDA-2025-S-0024-04532025-000537 - CanPrev Natural Health Products Ltd. - KSM-66-Ashwagandha - Support Stress…
979. FDA-2023-N-3902-0277Comment from Kim Shepherd
980. FDA-2007-D-0369-0649Draft Guidance on Lanthanum Carbonate - PSG_021468
981. FDA-2016-V-1141-0004Request to Renew Variance
982. FDA-2014-V-1023-0004Acknowledgement Letter from FDA DDM to Joseph Pisciotto
983. FDA-2018-V-4123-0002Acknowledgment Letter from FDA DDM to Guang Zhou Hao Yang Electronic Co., Ltd.
984. FDA-2014-H-1853-0001Complaint
985. FDA-2017-H-5243-0001Complaint
986. FDA-2024-S-0024-03422024-001063 - Reliance Vitamin Co. - Adult Calm † Chewable - SUPPORTS RELAXATION AND CALM…
987. FDA-2015-P-1553-0007Attachment 6 Citizen Petition Partial Approval and Denial Response from FDA CDER to TEVA…
988. FDA-1980-N-0038-0058Letter from Dermik Laboratories, Inc. (Covington & Burling) to J. Richard Crout
989. FDA-1976-N-0514-0009Memorandum of Telephone Conversation Between Coca-Cola, Co. and FDA - Background Material
990. FDA-1981-N-0083-0100Letter from John De Luca to Mary Custer
991. FDA-2023-H-3893-0001Complaint
992. FDA-2006-M-0432-0001FDA
993. FDA-2011-D-0618-0042Therapeutic Proteins International, LLC - Presentation
994. FDA-2018-D-4455-0002Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data…
995. FDA-1985-N-0132-0009Withdrawal of Certain Pre-1986 Proposed Rules; Final Action
996. FDA-2025-H-5408-0001Complaint
997. FDA-2015-V-2806-0001Variance Application from Dave Lovell
998. FDA-2011-N-0275-0007Agency Information Collection Activities; Proposed Collection; Comment Request…
999. FDA-2000-D-0221-0004FDA
1000. FDA-2020-V-1634-0001Variance Application from Bradley Potter