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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2023-H-0755-0001.
- FDA-2012-S-1144-2665Perrigo - CareOne®- Advanced Eye Health - EPA and DHA are essential fatty acids that help…
- FDA-2016-E-1275-0002Letter from U.S. Patent and Trademark Office
- FDA-2016-H-0461-0002Complaint
- FDA-2024-H-3519-0001Complaint
- FDA-2015-H-4725-0001CTP CMP Case re Boyer Mini Market I Inc. d/b/a Boyer Mini Market
- FDA-2017-N-1003-0046Request for Participation (ELP) from Medtronic
- FDA-2011-S-0932-1693Dee Cee Laboratories, Inc. - #978 Buffered C - Supports Antioxidant Health and Immune…
- FDA-2007-N-0083-0008M. Kremzner - Request for Appearance
- FDA-2016-E-2463-0005Determination of Regulatory Review Period for Purposes of Patent Extension; NINLARO
- FDA-2001-Q-0085-0020Supplement Information (Studies 1, 2, 3) from Rhodia Inc & Quaker Oats Company
- FDA-2017-H-6796-0001Complaint
- FDA-2019-H-0616-0001Complaint
- FDA-2025-H-2257-0001Complaint
- FDA-1993-N-0023-0002Neurological Devices; Effective Date of Requirement for Premarket Approval of Cranial…
- FDA-2020-V-0767-0003Letter from FDA CDRH to Roumen Lefterov
- FDA-2016-M-1165-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
- FDA-2011-N-0002-0094Workshops: Clinical Trial Requirements, Regulations, Compliance, and Good Clinical…
- FDA-2016-N-3120-0443Reference 75 (see abstract) re Request for Hearing from Kremers Urban Pharmaceuticals…
- FDA-2022-N-0736-0001NOOH letter from FDA ORA to Gregory Settino_Redacted
- FDA-2004-E-0330-0011Patent Term Extension Application - Exhibit B
- FDA-2019-H-5288-0001Complaint
- FDA-2012-V-0768-0002Acknowledgement Letter to Elev8d LLC
- FDA-2010-P-0171-0004Attachment 3 - "Additions/Deletions for Prescription Drug Product List" - [Sun…
- FDA-1978-N-0018-0018Interim Response Letter from FDA CDER to Rona
- FDA-2003-V-0415-0002HFA-305 to GEKD, Inc.
- FDA-1995-N-0054-13712Background Material for NFR 1
- FDA-2014-D-0055-0010Reference 17-000 List of References re Voluntary Sodium Reduction Goals: Target Mean and…
- FDA-2019-N-3325-0027Reference 2: FDA Draft Guidance for Industry, “Submission of Laboratory Packages by…
- FDA-1977-N-0022-0041Reference 108- Twiehaus, M.J., "Control of Anaplasmosis by Feeding An Antibiotic…
- FDA-2014-N-0189-36456Request for Extension from William R. Boulter
- FDA-2017-H-1854-0001CMP Complaint Issued to Peck Petroleum Corp. d/b/a Arco / Gourmet Espresso Mart
- FDA-2006-P-0331-0003Acknowledgment Letter from FDA DMB to Rakoczy Molino Mazzochi Siwik LLP
- FDA-2020-D-0957-0152152-[510(k)]-Submissions-for-Chemical-Indicators
- FDA-2019-V-4506-0004Variance Approval Letter from FDA CDRH to Kinetic Designs LLC
- FDA-1997-S-0039-0732Planetary Ayurvedics - Letter
- FDA-2012-N-1037-0065Reference 34 - Centers for Disease Control and Prevention, “Making Healthcare Safer…
- FDA-2023-H-4479-0001Complaint
- FDA-2015-N-3469-0126Nomination from Outsourcing Facilities Association
- FDA-1994-F-0109-0002Environmental Assessment from Sandoz Huningue S.A re FAP4B4423
- FDA-2017-N-6730-0001Center for Devices and Radiological Health; Medical Devices and Combination Products…
- FDA-2017-H-4098-0001CMP Complaint Issued to Bhavya Corporation d/b/a Pleasure Isle
- FDA-1997-N-0041-0025FDA Response to Knoll Pharmaceutical Company - Petition Denial (PDN2)
- FDA-2019-N-5900-0030Agency Information Collection Activities; Announcement of Office of Management and Budget…
- FDA-2023-E-3305-0003Letter from FDA CDER to U.S. Patent and Trademark Office
- FDA-2014-V-1806-0001Variance Application from Salsa Sensation Latin Dance Studio
- FDA-2024-H-4056-0001Complaint
- FDA-2011-P-0881-0004FDA/CDER to Pharmaceutical Security Institute, Inc. - Petition Denial
- FDA-2007-E-0398-0002FDA Center for Drug Evaluation Research to the USPTO - Letter
- FDA-2023-F-5500-0002Environmental Assessment Phase 1) Chromium Propionate in Turkey Diets
- FDA-2008-P-0473-0001AngioScore, Inc. - Citizen Petition
- FDA-2015-V-2869-0002Acknowledgement Letter from FDA DDM to Odyssey Entertainment
- FDA-2022-H-2598-0001Complaint
- FDA-2019-H-3876-0001Complaint
- FDA-2009-S-0608-0088NDI 587 - Androsta-l,4,6-triene-3,17-dione from Proprietary Wellness
- FDA-2018-P-1808-0003Attachment 1 Orange Book re Citizen Petition from Lachman Consultant Services, Inc
- FDA-2014-N-0189-3299Request for Extension from Anonymous
- FDA-2017-N-6189-0650Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; Extension of Comment…
- FDA-2016-H-0917-0002Complaint
- FDA-2015-H-0062-0001Complaint
- FDA-1997-S-0039-1791NBTY, Inc. - Ear Care Formula with Bioflavonoids - Supports Ear Health through Antioxidant…
- FDA-2007-P-0405-0004Matrix Laboratories, Inc. - Attachment 2: KALETRA Tablets/Oral Solution Information
- FDA-2002-P-0245-0003Final Response from FDA CDER to Lachman Consultant Services, Inc.
- FDA-2022-E-0767-0005Determination of Regulatory Review Period for Purposes of Patent Extension; PORTICO…
- FDA-1996-N-0270-0308Request for Extension from NRA & APPI
- FDA-2010-P-0322-0002Acknowledgement Letter to Amgen Inc.
- FDA-2015-S-0024-3484NOW - Ginkgo Biloba 120 mg - Supports Cognitive Function
- FDA-1975-N-0012-0052Electronic Correspondence from Ciba to FDA July 21, 2009
- FDA-2016-P-3560-0002Acknowledgment Letter from FDA DDM to Orchid Healthcare (A Division of Orchid Pharma Ltd.)
- FDA-1994-P-0054-0012FDA Executive Secretariat Response to Robert Cohen - Letter
- FDA-2021-V-0161-0002Acknowledgment Letter from FDA DMS to Andrew Shelton
- FDA-2013-D-1170-0001Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing…
- FDA-2021-S-0024-10782021-001377 - Pharmavite LLC - Nature Made Prenatal Multivitamin Softgel - may help…
- FDA-2014-P-0282-0003Memorandum from FDA CDER to Custo Pharm, Inc.
- FDA-2004-P-0100-0001Acknowledgment Letter from FDA DMB to City of Arlington Texas
- FDA-2015-V-1127-0001Variance Application from Eastside Cannery Casino & Hotel
- FDA-2021-S-0024-04282021-000640 New Generation Wellness Inc - Bengal Bites Chewable Tablet - promotes healthy…
- FDA-2009-S-0607-1188Perrigo - Welby Calcium - Vitamin D to Help Calcium Absorption
- FDA-1998-P-0398-0003Exhibit C - "April 9, 1998 Letter From Duramed Pharmaceuticals to the National Black…
- FDA-1989-G-0391-0107Appendix A Revised Environmental Assessment re: Fifth Supplement from Kellogg Company…
- FDA-1991-P-0355-0044Reference List from FDA/CFSAN (HFF-414)
- FDA-2020-S-0024-12212020-001433 - PYM Health, Inc. - PYM Original Mood Chews - Support for Overwhelm, Anxiety…
- FDA-2013-S-0024-0010NBTY Inc Turmeric, Omega 3 and Bromelain supplement Letter
- FDA-2017-S-0024-08312017000999 - International Vitamin Corporation - MULTIPLE CLAIMS (6)
- FDA-2010-S-0664-0526Country Life - Coenzyme Active B-6 Caps - Energy Production
- FDA-2017-S-0023-0051NDI 1002 - Massage Oil from V.A. Worldwide Ltd
- FDA-2024-E-3545-0003Letter to U.S. Patent and Trademark Office
- FDA-2024-N-5933-0096Kahan 2020
- FDA-2006-E-0507-0006FDA/CDER to the USPTO - Letter
- FDA-2015-P-0569-0003Exhibits A to F Citizen Petition From Koch Parafinczuk and Wolf, P.A.
- FDA-2016-H-1338-0001Complaint
- FDA-1977-N-0002-1162Answer Letter from FDA/Office of Legislative Services to Honorable Eldon Rudd, House of…
- FDA-2025-P-0434-0002Acknowledgment Letter from FDA DMS to Senores Pharmaceuticals, Inc.
- FDA-2011-N-0146-0202Reference 3: FDA Office of Foods and Veterinary Medicine Memorandum to the Division of…
- FDA-2024-H-3093-0001Complaint
- FDA-1997-S-0006-1657Courtesy letter and related material from CFSAN to Kion, LLC
- FDA-2017-V-4655-0003Variance Approval Letter from FDA CDRH to MODLIFESTYLES
- FDA-2023-V-1296-0002Acknowledgment Letter from FDA DMS to Chitwood Studios
- FDA-2008-D-0096-0044Reference-52-FSIS-Controlling-LM-Retail re Control of Listeria monocytogenes in…
- FDA-2018-S-0023-0125NDI 1086 - Lactobacillus Plantarum CJLP55 - Reference List
- FDA-2023-H-0253-0001Complaint
- FDA-2018-H-3520-0001Complaint
- FDA-2010-S-0664-0784NBTY, Inc. - L-Methionine - Support Fat Metabolism
- FDA-2009-S-0607-0516Perrigo - equaline B-12 - Supports Nervous System Health
- FDA-1986-G-0007-0022Report 12 Maltitiol GRAS Affirmation Petition (Part 2 of 3) re Citizen Petition from Towa…
- FDA-2010-P-0188-0009Exhibit M - "FDA Letter to American Pharmaceutical Partners, Inc., re Calcitrol Injection…
- FDA-2019-E-1080-0005Determination of Regulatory Review Period for Purposes of Patent Extension; TAVALISSE
- FDA-1987-N-0010-0136Background Material
- FDA-2011-D-0287-0023Reference 76 - "Federal Joint Subcommittee on Aquaculture, April 2007, Guide to Drug…
- FDA-2006-P-0535-0004Acknowledgment Letter from FDA DMB to Olsson, Frank and Weeda, P.C.
- FDA-2016-V-1379-0002Acknowledgement Letter from FDA DDM to Killer Audio
- FDA-2016-P-0645-000846. FDA-2012-P-0895-0015 FR re Request FDA uniformly apply its standards for permitting a…
- FDA-2016-H-4231-0001Complaint
- FDA-2002-N-0265-0038Smith & Nephew, Inc. - Electronic Request for Appearance
- FDA-2012-S-1144-0470NBTY, Inc. - Papaya Enzyme supplements under the Radiance label - As the perfect "after…
- FDA-2012-S-1144-2130Cott Beverages, Inc. - Kroger B-Vitamins and Amino Acid Dietary Supplement (Extra Strength…
- FDA-2004-N-0188-0095Reference 29 vCJD Key Facts re Use of Materials Derived From Cattle in Human Food and…
- FDA-1997-S-0039-1775Perrigo Company of South Carolina - Dollar General®- Hair, Skin & Nails - Antioxidants may…
- FDA-2000-P-1400-0010Attachment 9 September 21 1999 Press Release re Citizen Petition from Genelabs…
- FDA-2025-N-1114-0001NOOH Letter from FDA OII to Jason Oppenheimer
- FDA-2014-E-2326-0008Letter from FDA CDER to the U.S. Patent and Trademark Office
- FDA-2020-N-2029-0310References 7 RE Covis Pharma GmbH’s Briefing Materials In Response To The Center for Drug…
- FDA-2018-V-3808-0004Variance Amendment Request from Clay Paky S.p.A to FDA CDRH
- FDA-2016-S-0024-1049Lief Organics - C-Load - Vitamin C and all other ingredients
- FDA-2016-N-0124-0384Lonza Inc. A Pivotal Maximal Use Study to Measure the Systemic Absorption of Benzalkonium…
- FDA-2004-N-0048-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Medical…
- FDA-2006-P-0136-0005Background Materials re: Citizen Petition from Vintage Pharmaceuticals, LLC - Search…
- FDA-2009-S-0607-0280Perrigo - Multiple claims - 3
- FDA-1980-N-0049-0120Letter from David Panzera to FDA/DDM re: Electronic Comment from Mr. David Panzera
- FDA-2009-S-0607-1685New Chapter, Inc - Probiotic Cleanse - To help promote bowel detoxification and overall…
- FDA-2020-S-0024-0551SFC2020-000682 Genexa- Genexa Kids' Honey Cough Syrup- Support immunity-
- FDA-2001-D-0129-0010Declaration of Fritz L. Lorscheider, Ph.D. (Ref: FDA-2001-D-0129-0008)
- FDA-2024-H-5364-0001Complaint
- FDA-2016-H-0692-0001CTP CMP Case re Speedway LLC d/b/a Speedway 03473
- FDA-2004-V-0362-0001HFA-305 to G and G Sound and Lighting
- FDA-1997-S-0039-1772Perrigo Company of South Carolina - Vitasmart® - D - Bone Health
- FDA-2010-D-0503-0001Draft Guidance for Industry: Investigational New Drug Applications; Determining Whether…
- FDA-2019-N-3065-0606Reference 11 - Required Cigarette Health Warnings, 2020
- FDA-2019-D-1650-0001Magnetic Resonance Coil— Performance Criteria for Safety and Performance Based Pathway…
- FDA-2017-D-4713-0002Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products…
- FDA-2024-H-1443-0001Complaint
- FDA-2024-S-0024-01512024-000658 - ATP CO. LTD. - Beme WELLNESS Be Sharp- Support Mental Wellness
- FDA-2007-D-0369-2308PSG_219015 - Draft Guidance on Minocycline Hydrochloride
- FDA-1996-G-0303-0009List of References re: GRAS Affirmation Petition from FMC Corporation
- FDA-2016-H-1959-0001Complaint
- FDA-2011-N-0922-0544Reference 6. FRIA - Banfield State_of_Pet_Health_2012 re Current Good Manufacturing…
- FDA-2013-E-0782-0001Talon Therapeutics, Inc. (on behalf of Kenyon & Kenyon, LLP) - Patent Extension…
- FDA-2004-E-0269-0008U.S. Patent & Trademark Office
- FDA-2010-N-0180-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adoption…
- FDA-1997-S-0039-1104Perrigo Company of South Carolina - Good Health-Magnesium - Bone Health
- FDA-2025-H-1205-0001Complaint
- FDA-2010-S-0664-0505Reliance Vitamin Company, Inc. - Strawberry Banana Flax Fusion - Heart Healthy
- FDA-2016-H-0194-0002Complaint
- FDA-2010-S-0664-2228Perrigo - H-E-B Dairy Digestive - Prevnet Gas, Bloating and Diarrhea
- FDA-2006-E-0263-0007Scios Inc. - Patent Term Extension Application
- FDA-2007-P-0183-0007Acknowledgement Letter - Purdue Pharma L.P.
- FDA-2010-S-0665-0188NDI 668, EstroG-100 from Sunbio Corporation
- FDA-2010-D-0194-0018Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft…
- FDA-2024-H-4434-0001Complaint
- FDA-1997-S-0006-0153HFS-800 to New Chapter Inc
- FDA-2025-H-1209-0001Complaint
- FDA-2018-N-4626-0160Nomination from Wedgewood Pharmacy
- FDA-2014-N-0189-4720Request for Extension from Anonymous
- FDA-2019-E-3294-0009Notice of Final Determination and Requirement for Election Letter from U.S. Patent and…
- FDA-2005-P-0375-0002Acknowledgement Letter from FDA DDM to Consumers for Dental Choice
- FDA-2014-S-0024-0240Waterpure, Inc (Fun Greens) - Letter
- FDA-2017-H-5345-0001Complaint
- FDA-2018-H-3701-0001Complaint
- FDA-2023-E-1620-0002Patent Extension Application from Goodwin Procter LLP (on behalf of Agios Pharmaceuticals…
- FDA-2012-N-1239-0001Dental Devices: Reclassification of Temporary Mandibular Condyle Prosthesis
- FDA-2023-H-0586-0001Complaint
- FDA-2012-P-0272-0001Actavis Inc. - Citizen Petition
- FDA-1996-P-0030-0001Memorandum of Telephone Conversation between Hyman, Phelps & McNamara, P.C. and FDA
- FDA-2024-S-0024-04692024-001292 - Luminary Vitamins LLC - Luminary Vitamins, Form- support your body during…
- FDA-2013-V-0864-0001Laser Safety Services (Yuma Crossing National Heritage Area Corporation) - Application for…
- FDA-1980-N-0038-0033Request for Hearing from The Upjohn Company
- FDA-2025-S-0024-15482025-001669 - Schwabe North America Inc - MULTIPLE CLAIMS (3)
- FDA-2020-V-0348-0003Letter from FDA CDRH to Smiths Auto Service Inc
- FDA-2015-S-0024-0079NBTY Inc - Vitamin E supplements - Supports healthy heart and immune system
- FDA-2017-H-0225-0001Complaint from FDA CTP to RMJO Enterprises, Inc. d/b/a Exxon Food Mart
- FDA-2006-N-0304-0038Graceway Pharmaceuticals, LLC - Supplement Comment re FDA-2006-N-0304-0032
- FDA-2009-P-0587-0009Tab 13 - Wolf T. et al, "Folic Acid Supplementation for the Prevention of Neural Tube…
- FDA-2017-H-6023-0001Complaint
- FDA-2016-H-0293-0001CTP CMP Case re 8 Till Late 16 South, Inc. d/b/a 8 Till Late 16 / Shell
- FDA-1976-N-0027-0081Tab 12 81N-0022, Vol 5, CP 5 without attachments re Citizen Petition from Thompson Medical…
- FDA-2011-S-0932-2221NOW Foods - Herbal Pause with EstroG-100 - Natural Menopause Relief
- FDA-2014-N-1051-0686685 7694105 Survey Subject R3027_Redacted
- FDA-1979-P-0020-0005Variance Approval Letter from FDA CDRH to Eastern Florida State College Planetarium
- FDA-2024-V-5745-0002Variance Acknowledgment Letter from FDA DMB to Self
- FDA-2023-N-2177-7011Reference 161 - FDA Response to Request for Comment Period Extension
- FDA-2023-N-3902-0432Comment from Samantha Perry
- FDA-1977-N-0014-0960Answer Letter from FDA to Comment from The Honorable Larry Winn, Jr., United States House…
- FDA-2021-S-0024-14332021-001564 - Swanson Health Products 11658148874- Swanson Health Products, Gummies…
- FDA-2000-N-0109-0060Corrected May 6, 2003 Transcript
- FDA-2007-N-0198-0002FDA/CFSAN/ONLDS
- FDA-2024-H-1578-0001Complaint
- FDA-2014-H-1864-0001Complaint
- FDA-1993-G-0218-0494Table D-1: Part D: MRCA Report for Oat Fiber(continued) - As Consumed Levels of Oat Fiber…
- FDA-2007-N-0442-0001FDA
- FDA-2015-H-3652-0001CTP CMP Case re Lynn Pederson d/b/a Gate City General
- FDA-2026-P-0056-0001Suitability Petition from Regulatory Compliance Solutions LLC (on behalf of Flea Assassin…
- FDA-1997-S-0039-2275Perrigo Company of South Carolina - Meijer Calcium Citrate+ - Bone Health
- FDA-2023-V-5238-0003Variance Approval Letter from FDA CDRH to Seiko Epson Corporation
- FDA-2025-H-3892-0001Complaint
- FDA-2023-S-0023-0040NDI 1287 - Golden Caps from Nourished Vines, LLC
- FDA-1990-S-0006-0237HFD-7 - Memo - Ted Sherwood
- FDA-2015-N-0101-0910Reference 39-67 - FDA-1975-N-0012-0258 --- CP16 re Safety and Effectiveness of Health Care…
- FDA-2023-N-3902-0164Reference 136 - J Samuels, DOJ, letter re Banned Devices; Proposal To Ban Electrical…
- FDA-2024-H-3547-0001Complaint
- FDA-2016-H-3469-0001Complaint
- FDA-1987-P-0074-0005Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing…
- FDA-2024-V-1793-0003Variance Approval Letter from FDA CDRH to Audio Video Export, LLC
- FDA-2017-H-2127-0001CMP Complaint Issued to Fresh Start Convenience Stores, Inc. d/b/a Fresh Start
- FDA-2013-V-1535-0002Acknowledgement Letter to Danni Productions LLC
- FDA-2010-S-0664-0174Vitacost.com, Inc. - NSI Acetyl L-Carnitine HCI & Acetyl L-Carnitine Arginate - Promote…
- FDA-2014-N-2244-0107Reference 99 eXtension_2014_Manure Pathogens and Microbial Byproducts re Draft…
- FDA-2019-S-0024-06962019002523 - 1159814 B.C. Ltd. - Yuva Caps - Supports cells by reducing the the oxidative…
- FDA-2005-V-0145-0004FDA/CDRH to Sapphire Nightclub - Letter
- FDA-2013-S-0024-0730Herbalife - Garden 7 Dietary Supplement (F1707-00) - Helps nourish cells and organs so…
- FDA-2020-P-1597-0013Appendix 13 RE: Petition for Administrative Stay of Action from Informed Consent Action…
- FDA-1977-N-0224-0137Answer Letter from FDA to Comment from The Honorable Paul Laxalt, United States Senate
- FDA-2023-N-2177-6885Reference 35 - “It Has Come to Our Attention” Letter to Texas Children’s Hospital and…
- FDA-2001-P-0123-0037Petition Response References
- FDA-2014-N-0189-5477Request for Extension from Anonymous
- FDA-2023-H-5646-0001Complaint
- FDA-2004-S-0571-0060NDI 190 - Creatine Ethyl Ester - Original NDI Notification
- FDA-2015-S-0024-3397Munuka Health New Zealand Ltd - Multiple claims - 2
- FDA-2015-H-0257-0001Complaint
- FDA-2021-V-0592-0002Acknowledgment Letter from FDA DMS to Spacebar Arcade
- FDA-2017-H-3294-0001CMP Complaint Issued to BG Singh LLC d/b/a Citgo Mart
- FDA-2010-S-0664-0366Perrigo - CVS Pharmacy Teen Multi-Vitamin - Support a Healthy Immune System
- FDA-2011-V-0764-0001Barry Willems - Application for Variance
- FDA-2016-H-0326-0002Complaint
- FDA-2016-H-0218-0001CTP CMP Case re Saleh and Nizar Corp. d/b/a Good To Go Food Mart and Fresh Deli
- FDA-2024-E-0135-0004Letter to U. S. Patent and Trademark Office
- FDA-2025-S-0024-05672025-000654 - Pharmavite LLC - Nature Made Focus Boost Capsules - help reduce mental…
- FDA-2013-S-0023-0001NDI 775 Guanidinoacetic acid from AlzChem AG
- FDA-2022-S-0024-06712022-000685 - MindBodyGreen LLC - brain guard - enhanced learning speed and promotes brain…
- FDA-2020-N-2319-0005Request for Extension from Society of Quality Assurance (SQA)
- FDA-1980-N-0038-0356Order from FDA
- FDA-2020-M-2248-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
- FDA-2014-P-1483-0003Withdrawal of Petition from Upsher-Smith Laboratories, Inc.
- FDA-2014-P-0328-0004Citizens Petition Approval Letter to Robert Dormer and Gordon Johnston
- FDA-1997-N-0010-0007Foundation for the Accreditation of Cellular Therapy (FACT) - Supplement(2)
- FDA-2022-E-2260-0001Letter from U.S. Patent and Trademark Office
- FDA-2023-H-3182-0001Complaint
- FDA-2015-V-1599-0002Acknowledgement Letter From FDA DDM to Gregory Richards
- FDA-2007-P-0183-0004Purdue Pharma L.P., & Rhodes Technologies - Letter
- FDA-2017-N-0763-0217215 Reference_214 Chan_2007_Isoflavone intake in persons at high risk of cardiovascular…
- FDA-2019-N-3065-0186Reference 184 - Women and Smoking _A Report of the Surgeon General, 2001 re Tobacco…
- FDA-1991-N-0365-0194Answer from FDA DDM to Honorable John E. Ware Re: Comment from Samuel F. Scheidy, M.D.
- FDA-2015-V-2798-0002Acknowledgement Letter from FDA DDM to Visceral Sight and Sound
- FDA-2017-H-5151-0001Complaint
- FDA-2015-P-1103-0003Interim Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.
- FDA-2019-N-4203-0034Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of…
- FDA-2019-H-0818-0001Complaint
- FDA-2015-S-0024-2154NBTY, Inc. - Niacinamide - Cardiovascular support
- FDA-1987-P-0132-0004Approval of Citizen Petition from FDA to Barr Laboratories, Inc.
- FDA-2020-V-1574-0001Variance Approval Letter from FDA CDRH to Ryan Rojany
- FDA-1993-G-0221-0026Revised Environmental Assessment from Agent for Foreign Domestic Chemicals Corporation
- FDA-2010-S-0664-1509North American Pharmacal, Inc. - D'Adamo Personalized Nutrition®, CIearCal - Unique source…
- FDA-2018-H-4040-0001Complaint
- FDA-1975-N-0016-0024Acknowledgement Letter from FDA/DDM to Xttrium Laboratories, Inc. (Kleinfeld, Kaplan &…
- FDA-2022-H-0957-0001Complaint
- FDA-2024-H-4005-0001Complaint
- FDA-2020-P-1601-0020Appendix 17 RE: Citizen Petition from Informed Consent Action Network
- FDA-2017-D-6530-0001Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of…
- FDA-2017-P-5787-0088Reference 86 Ko_CDER Medical Review_NDA 20-788_P4 (Dec-1997) re Citizen Petition Post…
- FDA-2004-P-0339-0017References for Citizen Peition Response
- FDA-2022-H-1521-0001Complaint
- FDA-2021-S-0024-14112021-3236 Waterpure dba Purity Products - MULTIPLE CLAIMS (6)
- FDA-2011-N-0921-19147Reference 2 Produce Ag Water compliance extension PRIA Sept 2017 re Standards for the…
- FDA-2007-N-0037-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Animal…
- FDA-2011-S-0932-2471Mission Endurance, LLC - Mission Endurance, SciTri Endurance Sports & Recovery Drink…
- FDA-2023-H-4618-0001Complaint
- FDA-2015-N-3469-0156Nomination from Triangle Compounding Pharmacy, Inc.
- FDA-2017-S-0024-0040The Nature's Bounty Co 9, Sundown Naturals® Kids Complete Multivitamin Gummies featuring…
- FDA-2025-P-2547-0006Attachment 4 - FDA Grant Response Letter - FDA-2020-P-0624
- FDA-2000-D-0075-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
- FDA-2024-V-3146-0001Variance Application from Kelly Ganley
- FDA-2004-P-0223-0005FDA - Notice of Meeting
- FDA-2004-N-0379-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
- FDA-2004-N-0451-0017Food and Drug Administration Modernization Act of 1997: Modifications to the List of…
- FDA-2007-E-0398-0012Patent Term Extension Application [ FDA-2007-E-0398-0004] - Exhibit F
- FDA-2011-S-0932-2884NBTY, Inc. - Giant Eagle Vitamin C 1000 mg Supplements - Helps Support Healthy Immune…
- FDA-1996-N-0028-0075Pre_FDMS - OMB Review 10/25/2005
- FDA-2012-D-0322-0039Ref 11. Analytical Results For Arsenic Lead Cadmium MercuryFood Intended For Babies And…
- FDA-2011-S-0932-2679NBTY, Inc. - Coenzyme Q-10 - Heart Support
- FDA-1997-S-0006-0210FDA/CFSAN to Beulah Land Corporation
- FDA-2025-V-2918-0002Variance Acknowledgment Letter from FDA DMB to Hershey Entertainment & Resorts
- FDA-2025-H-0632-0001Complaint
- FDA-2024-N-2177-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
- FDA-2025-S-0024-10982025-001184 - Healthy Decisions Inc - Pep - Pep reduces triglycerides in rodents fed high…
- FDA-2024-V-2156-0002Acknowledgment Letter from FDA DMS to Kyle Beatham
- FDA-2008-P-0242-0002National Toxic Encephalopathy Foundation - Citizen Petition
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- FDA-2022-H-1071-0001Complaint
- FDA-2021-M-0676-0002Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications
- FDA-2016-D-2335-1712Agency Information Collection Activities; Announcement of Office of Management and Budget…
- FDA-2011-S-0932-1914General Nutrition Corporation - Multiple claims - 28
- FDA-2014-P-1773-0002Acknowledgement Letter From FDA DDM to Pharmacits Planning Sercive Inc. (PPSI)
- FDA-2022-P-0200-0002Acknowledgment Letter from FDA DMS to Lachman Consultants Inc.
- FDA-1995-P-0281-0024Letter from Patton Boggs, L.L.P. (National Yogurt Association) to FDA CFSAN
- FDA-1976-N-0523-0001Notice of Availability of Draft Regulations Concerning Good Manufacturing Practices
- FDA-2022-N-3239-0001Medical Devices; Orthopedic Devices; Classification of the Implantable Post- Surgical…
- FDA-2016-H-1014-0002Complaint
- FDA-2017-H-3569-0001CMP Complaint Issued to Richie’s Too, Inc. d/b/a Richie’s Too
- FDA-1991-N-0014-0015FDA
- FDA-2025-H-7403-0001Complaint
- FDA-2021-S-0024-11762021-001492 - Hylands- Hyland's Naturals Organic Elderberry Plus- support immune health
- FDA-2019-E-5271-0005Determination of Regulatory Review Period for Purposes of Patent Extension; BARRICAID…
- FDA-2023-N-0155-0046Agency Information Collection Activities; Submission for Office of Management and Budget…
- FDA-2015-S-0024-1586NBTY - Quick Dissolve Melatonin supplements under the H-E-B - Helps promote relaxation and…
- FDA-2016-S-0024-1799NBTY - B-Complex 50 supplements - Supports energy metabolism
- FDA-2019-H-0965-0001Complaint
- FDA-2020-H-0295-0001Complaint
- FDA-2018-N-0981-0001Preparation for International Cooperation on Cosmetics Regulation Twelfth Annual Meeting…
- FDA-2023-H-0511-0001Complaint
- FDA-2002-D-0268-0004Draft Guidance Document re Pharmacovigilance of Veterinary Medicinal Products Controlled…
- FDA-2010-S-0664-159821st Century HealthCare, Inc. - Niacinamide Prolonged Release Tablets - Convert Food into…
- FDA-2005-V-0452-0004FDA Response to Night Vision Equipment Company for Approval for Variance - Letter
- FDA-2010-D-0164-0002Guidance for Industry; Studies to Evaluate the Metabolism and Residue Kinetics of…
- FDA-2015-S-0024-2147NBTY, Inc. - Biotin - Supports healthy hair, skin and nails
- FDA-1997-S-0039-1881Enzymatic Therapy, Inc. - PredictEase and Predict IB - A combination of probiotics, fiber…
- FDA-2014-H-1954-0001Complaint
- FDA-2022-S-0024-04002022-000406 - Atrium Innovations - Pure Encapsulations, Choline (bitartrate) - Supports…
- FDA-2026-H-0050-0001Complaint
- FDA-2003-P-0174-0005FDA - Proposed Rule - Pre-Pub
- FDA-2020-P-2289-0004Interim response to Loeb & Loeb, LLP from FDA CDRH
- FDA-2006-N-0250-0001Agency Information Collection Activities; Submission for Office of Management and Budget…
- FDA-2019-D-3805-0002The Accreditation Scheme for Conformity Assessment Pilot Program; Draft Guidance for…
- FDA-2020-D-1794-0010Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study…
- FDA-2016-H-3805-0001Complaint
- FDA-2008-P-0080-0004Acknowledgement Letter to Lupin Pharmaceuticals, Inc. - [FDA-2008-P-0080-0002]
- FDA-1992-N-0005-0006Memorandum of Telephone Conversation Between FDA to John Buonora on Behalf of Susan M…
- FDA-1997-S-0039-2192Perrigo - HEALTHsense - One Daily - Calcium & Vitamin D to promote strong bones & breast…
- FDA-2018-P-3730-0004Attachment 2 Drugs @ FDA re: Citizen Petition from Aizant Drug Research Solutions Pvt. Ltd
- FDA-2020-M-2094-0001Premarket Approval for BP180279, Avioq, Inc, VioOne™ HIV Profile™ Supplemental Assay
- FDA-2015-H-4037-0001CTP CMP Case re CSG Management Corp. d/b/a CSG Food Mart / Sunoco
- FDA-2015-H-4812-0001CTP CMP Case re Maynards Food Center of Westbrook Inc. d/b/a Maynard’s of Akron
- FDA-2024-P-0425-0006Amended Suitability Petition from RegCon Solutions, LLC
- FDA-2025-H-3329-0001Complaint
- FDA-1977-N-0019-0065Answer Letter from FDA to Comment from The Honorable John D. Dingell, U. S. House of…
- FDA-2023-H-4861-0001Complaint
- FDA-2014-N-0189-9781Request for Extension from Anonymous
- FDA-2023-N-3902-1445Comment from Jennifer Grace
- FDA-2014-N-2244-0002List of Referencesre Draft Environmental Impact Statement for the Proposed Rule, Standards…
- FDA-2019-N-5959-0018Reference 15 - National Association of Chain Drug Stores - Citizen Petition Requesting FDA…
- FDA-2005-E-0188-0007FDA/CDER to the U.S. Patent and Trademark Office
- FDA-1980-N-0038-0419Certificate of Service re: Written Direct Testimony of Howard I. Maibach, M.D. for…
- FDA-2015-H-1138-0001Complaint
- FDA-2016-D-0734-0012Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device…
- FDA-1994-F-0434-0002Atlantis Corp.; Filing of Food Additive Petition
- FDA-2016-H-3860-0001Complaint
- FDA-2013-N-1524-2155Nomination Letter Pyridoxine Hydrochloride USP (Vitamin B6 HCl) re: Comment from Fagron
- FDA-2015-V-1554-0001Variance Application from Jonathan Wilson
- FDA-2003-D-0186-0002Guidance
- FDA-2004-N-0202-0001Medicare Prescription Drug, Improvement, and Modernization Act of 2003; Study on Making…
- FDA-2017-P-4575-0184Reference 177 - Beneficial nutritional properties of olive oil - implications for…
- FDA-2007-D-0369-1348PSG_016769 - Draft Guidance on Flavoxate Hydrochloride
- FDA-2015-H-4606-0001CTP CMP Case re Tejspann LLC d/b/a Superway Food Mart
- FDA-2011-D-0893-0001Draft Guidances for Industry and Staff; Availability: Center for Devices and Radiological…
- FDA-2022-P-1049-0001Suitability Citizen Petition from Noble Pharma LLC
- FDA-2017-P-6028-0001Citizen Petition from Axinn, Veltrop & Harkrider LLP
- FDA-2019-H-5384-0001Complaint
- FDA-2015-S-0024-1534Nutrition Express - Lindberg® Sunflower E 400 IU - For Heart, Skin and Cellular Health
- FDA-2016-E-1265-0004Letter from U.S. Patent and Trademark Office
- FDA-2024-E-0218-0010Letter from FDA CDER to U.S. Patent and Trademark Office
- FDA-2015-N-2523-0001Intent To Review a Study Data Reviewer’s Guide Template
- FDA-2023-D-1716-0058Registration and Listing of Cosmetic Product Facilities and Products; Guidance for…
- FDA-2017-H-5303-0001Complaint
- FDA-2019-S-0024-05862019-2610 Futurebiotics LLC - MULTIPLE CLAIMS (2)
- FDA-2009-E-0206-0007FDA/CDER to U.S. Patent and Trademark Office - Letter
- FDA-2018-S-0024-0658Solvotrin Therapeutics- Active Iron High Potency- supports the formation of haemoglobin…
- FDA-2024-V-4468-0002Acknowledgment Letter from FDA DMS to EOTECH, LLC
- FDA-2020-V-2026-0003Letter from FDA CDRH to Darry Kurpisz
- FDA-1999-N-0134-0090Risk Assessment
- FDA-2016-S-0024-1418Perrigo Company - Shopko®- CENTURY - Immune Support
- FDA-2006-E-0200-0002U.S. Patent and Trademark Office to Mark D. Passler
- FDA-2023-H-0833-0001Complaint
- FDA-1987-N-0010-0259Background Material
- FDA-2013-H-1335-0001Complaint
- FDA-2021-S-0024-13922021-2636 Rightful LLC - MULTIPLE CLAIMS (5)
- FDA-2002-P-0046-0003Citizen Petition from Arla Foods Ingredients amba (Hyman, Phelps & McNamara, PC)
- FDA-2016-H-3262-0001Complaint
- FDA-2022-H-3397-0001Complaint
- FDA-2012-P-1107-0033Oxiplex®/SP Gel; FzioMed, Incorporated’s Petition for Review of the Food and Drug…
- FDA-2006-E-0195-0001U.S. Patent and Trademark Office
- FDA-2015-N-0101-0610Reference 12-49 - FDA-1975-N-0012-0115 --- C42 Kao Corp of America 1-17-1996 re Safety and…
- FDA-1976-N-0476-0593Letter from Jean M. Taylor to Samuel I. Shibko
- FDA-2019-H-0872-0001Complaint
- FDA-2010-D-0645-0003Guidance for Industry and Staff - Class II Special Controls Guidance Document: Contact…
- FDA-2015-H-1067-0001Complaint
- FDA-2023-N-2177-6883Reference 33 - FDA, “Policy for Coronavirus Disease-2019 Tests (Revised); Guidance for…
- FDA-1983-M-0010-0042FDA/Office of Health Affairs to Rainer-Sadler, M.D., P.C.
- FDA-2015-S-0024-3058Bluebonnet Nutrition Corporation - Cellular Active® Coenzyme B-Complex Capsules - This…
- FDA-2024-S-0024-04422024-001260 - Kaged - KAGED, Pre-Workout Sport- PROMOTES FOCUS
- FDA-1991-P-0355-0014Tab I Section 6 Potential Problems w/Ultrapasteurized Egg Product; Recommendations and…
- FDA-2015-N-0030-8454Final Standard MOU Addressing Certain Distributions of Compounded Human Drug Products…
- FDA-1998-N-0575-0002Agency Information Collection Activities; Announcement of OMB Approval; Guidance for…
- FDA-2020-E-1588-0003Patent Term Extension letter from FDA CDER to The Honorable Andrei Lancu
- FDA-2016-N-3118-0376256_FAERS
- FDA-2016-H-0108-0001CTP CMP Case re Pilot Travel Centers LLC d/b/a Pilot Travel Centers 096
- FDA-2020-P-1510-0007Appendix #9 “Over-the-Counter Drug Review,” 21 CFR part 330.1 RE: Citizen's Petition from…
- FDA-2009-D-0542-0016Guidance for Industry: Distinguishing Liquid Dietary Supplements From Beverages
- FDA-2007-E-0102-0016U.S. Patent and Trademark Office to Sidley Austin LLP - Notice of Final Determination and…
- FDA-2024-N-5471-0561Reference 559 Cornelius Trends in cigarette pricing and 2015
- FDA-2020-V-1890-0001Variance Application from Jacob Berg Potter
- FDA-2018-P-0998-0003Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5…
- FDA-2010-S-0664-2235Perrigo - Walgreens A thru Z Select - Bone Health
- FDA-2015-H-0130-0001Complaint
About this dataset
Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.
Source: Regulations.gov (U.S. General Services Administration eRulemaking Program)