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Regulations.gov documents

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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2017-H-0213-0001.

FDA-2022-V-1267-0003Variance Approval from FDA CDRH to Put The Flag Up, LLC
FDA-2004-P-0285-0011FDA/CDRH to Endotec, Inc.
FDA-2015-N-0101-0130Reference 7-121 - FDA-1975-N-0012-0081 -- C12 Ref - 119_Lopes 1991 re Safety and…
FDA-2017-P-1039-0001Citizen Petition from Beck & Thomas
FDA-2015-S-0024-3231Dymatize Nutrition - Aminopro - Dymatize developed the new PerformanceDriven line with…
FDA-2016-N-2527-0064Reference 57 - EPA, Risk Assessment Guidance re Tobacco Product Standard for…
FDA-2024-N-5471-0253Reference 251 Philip Morris U Alkaloid Reduced Tobacco 1994
FDA-2007-E-0164-0007Determination of Regulatory Review Periods for Purposes of Patent Extension: Altabax…
FDA-2016-S-0024-1469NOW foods - Tribulus - Tribulus terrestris has been used for centuries in ancient Greece…
FDA-1999-P-1857-0002Attachment A FDA CDER Guidance for Industry Labeling Guidance for Butalbital…
FDA-2018-S-0023-0007NDI 1054 - Agave salmiana sap concentrate from AGMEL SA DE CV
FDA-2016-S-0024-0414Scitec Nutrition Inc - Greens & Fruit Superfood - Wheat grass and Spirulina help to…
FDA-1980-N-0074-0061HFD-560 to Buc & Beardsley
FDA-2015-M-1177-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2023-N-3902-1794Comment from Terra Garsat
FDA-2017-H-4364-0001CMP Complaint Issued to Circle K Stores Inc. d/b/a Circle K
FDA-2024-N-5471-0437Reference 435 - Perkins Sex differences in the influence 2006
FDA-2003-D-0089-0002Guidance
FDA-2015-N-3469-0340Nomination from OUTSOURCING FACILITIES ASSOCIATION
FDA-2021-V-0480-0001Variance Application from Hopper Visuals
FDA-2016-S-0024-1658Church & Dwight Co., Inc. - vitafusion™ Relaxed Mood - Promotes calm & relaxation with 200…
FDA-2006-P-0458-0004Background Materials re: Citizen Petition from Lupin Pharmaceuticals, Inc.- Enclosure1…
FDA-1995-P-0016-0145Background Material in 94P-0390
FDA-2016-S-0024-1427Valeant - PreserVision AREDS2+Multivitamin - Help support macular health
FDA-2010-S-0664-2601Perrigo - Exchange Select Century Mature - Prostate Health
FDA-1977-N-0028-0016Tab 17: Rapoport, I. A., "The Effect of Ethylene Oxide, Glycide, and Glycol on Genie…
FDA-2019-P-1198-0001Citizen Petition from KIND LLC
FDA-1984-G-0019-0133Letter from Solvay Enzymes to FDA
FDA-2005-S-0518-0037NDI 267 - Kaneka Glavanoid Rich Oil brand of Licorice Flavanoid Oil (LFO) from Kaneka…
FDA-2016-P-1212-0003Attachment 1 Approved labeling for the RLD, Excedrin (migraine) re Citizen Petition from…
FDA-2023-H-0442-0001Complaint
FDA-2014-N-0189-7015Request for Extension from Anonymous
FDA-2015-N-0101-1354002 Reference 2 -1 - Volume_I_1_of_9_Soap_and_Detergent_Association_SDA_Comment_re_Comment…
FDA-2013-N-0227-0204Reference 135 Philip Morris Process Validation Philip 2001
FDA-2007-P-0180-0005National Cancer Institute - A Snapshot of Sarcoma
FDA-2020-D-1370-0027COVID–19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance…
FDA-2005-P-0364-0002HFA-305 to Ivax Pharmaceuticals, Inc.
FDA-2022-V-0435-0002Acknowledgment Letter from FDA DMS to Investment Recovery Services
FDA-2019-V-5304-0001Variance Application from Showdown Productions
FDA-1996-N-0006-0006Response from FDA/CDER to BASF AG [Morgan, Lewis & Bockius, LLP]
FDA-2024-H-2034-0001Complaint
FDA-2016-S-0024-0169Doctor's Best, Inc. - High Absorption CoQ10 with BioPerine® (DRB-00412) - CoQ10 is very…
FDA-1973-N-0001-0002Pt. 600.15 Proposed Requirements Regarding Temperatures During Shipment of Live Measles…
FDA-2007-N-0218-0006Supporting Statement - Submission of Petitions: Food Additive, Color Additive (Including…
FDA-2024-V-3738-0002Acknowledgment Letter from FDA DMS to Garrison Wininger
FDA-2020-H-0063-0001Complaint
FDA-2009-S-0607-1131Perrigo - Vitasmart B6 - Enhances the Body's Utilization of Fatty Acids and Helps Maintain…
FDA-2008-N-0549-0044OCC SOF PEG3350
FDA-2017-H-5774-0001Complaint
FDA-2018-S-0024-07422018-5860 Mondelez Global LLC.- Halls Defense Assorted Citrus, Sugar Free Assorted Citrus…
FDA-2025-H-5413-0001Complaint
FDA-2025-S-0023-0053NDI 1397 - ALH-L1005 from AngioLab Inc.
FDA-2008-N-0341-0007Agency Information Collection Activities; Proposals, Submissions, and Approvals…
FDA-2020-V-1632-0002Acknowledgment Letter from FDA DMS to Charlie Osceola
FDA-2024-H-1137-0001Complaint
FDA-2025-V-0216-0003Variance Supplement from Blue Sky Yachts
FDA-2024-S-0024-07992024-001663 - Zebora Biotech Corp - ZEBORA, OMEGA 3-6-9 - SUPPORTS HEART HEALTH and…
FDA-2015-S-0024-2158NBTY, Inc. - Krill Oil - Heart health
FDA-2022-E-2095-0004Determination of Regulatory Review Period for Purposes of Patent Extension; WELIREG
FDA-2022-V-1291-0003Variance Approval from FDA CDRH to Glenn Stephens
FDA-2018-S-0024-0663International Vitamin Corporation- Meijer Fenugreek 610 mg Capsules- SUPPORT GENERAL…
FDA-1994-P-0041-0039BACKGROUND
FDA-2022-V-2318-0002Acknowledgment Letter from FDA DMS to George Stathakopoulos
FDA-2017-H-2945-0001CMP Complaint Issued to Borsho Stores Inc. d/b/a Atlantic Food Store
FDA-2007-D-0369-2207PSG_207500 - Draft Guidance on Isavuconazonium Sulfate
FDA-2015-H-3967-0001CTP CMP Case re Springfield Market LLC d/b/a Springfield Market
FDA-1976-N-0476-0292Memorandum of Telephone Conversation between Mr. Sheldon Mazursky, Litton Bionetics and…
FDA-2017-H-1373-0001CMP Complaint Issued to Fresh Start Convenience Stores, Inc. d/b/a Fresh Start
FDA-2013-S-0024-0777Source Naturals - Kava - Clinical studies indicate kava may help with occasional anxiety
FDA-2003-H-0215-0001HHS/FDA/CDRH
FDA-2016-N-0001-0041Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice
FDA-2018-H-3391-0001Complaint
FDA-2006-N-0242-0005Supporting Statement for Threshold of Regulation Policy for Food-Contact Articles
FDA-2020-V-2274-0002Acknowledgment Letter from FDA DMS to Renegade 5d
FDA-1997-S-0039-0752Wyeth Consumer Healthcare - letter
FDA-2018-H-4075-0001Complaint
FDA-2017-H-5444-0001Complaint
FDA-2019-S-0024-03042019002293 - Pfizer Consumer Healthcare - Centrum MultiGummies Women 50+ - Support heart…
FDA-2021-N-1349-175889TAB A 2019-148 Menthol NPRM as Submitted to OMB
FDA-1987-N-0054-0065Exhibit G-138.37 pp.007-283 re: Disclosure of Data and Information from FDA/CDER (Vol 56…
FDA-2004-P-0151-0002Acknowledgement Letter to McNeil Consumer & Specialty Pharmaceuticals
FDA-2011-N-0012-0005Grant Funds; Availability: Cooperative Agreement; Strengthen and Promote Role of Local…
FDA-2013-N-0796-0009Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2003-N-0446-0030New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
FDA-2011-N-0921-19184Agency Information Collection Activities; Proposed Collection; Comment Request; Standards…
FDA-2007-D-0369-1696PSG_209805 - Draft Guidance on Ertugliflozin; Sitagliptin Phosphate
FDA-2019-N-4750-0041Memorandum to FDA DMS on Partially Hydrogenated Oils
FDA-2019-H-3521-0001Complaint
FDA-2015-S-0024-1233NBTY - Super B Complex supplements - Energy metabolism & immune health
FDA-2022-V-2811-0003Variance Approval Letter from FDA CDRH to LASERGATOR, INC.
FDA-2016-S-0024-1016Perrigo Company - Target - promotional - Helps support bone and immune system health
FDA-2017-D-0085-0016Reference-15-Cheng-Chiou-2008-Framing-effects-group-investment-decision-making-role-group…
FDA-2022-S-0024-05412022-000566 - Swanson Health Products 11658148874- Swanson Health Products, CALM SLEEP…
FDA-2012-E-1241-0004FDA/CDER to U.S. Patent and Trademark Office - Letter
FDA-2014-S-0024-0280Perrigo (H E B Eye Health and Lutein) - Letter
FDA-2017-P-5124-0005Medical Devices: Exemption from Premarket Notification; Class II Devices; Over-the-Counter…
FDA-2018-N-4626-0048Nomination from Wedgewood Pharmacy
FDA-2025-N-1793-0003Reference 1 - Murphy, S.L., Kochanek, K.D., et al., “Mortality in the United States…
FDA-2023-N-3902-0500Comment from Linda Sandifer
FDA-2025-H-2141-0001Complaint
FDA-2013-S-0024-0847NOW Foods - Chondroitin Sulfate - Joint Health, Tissue Elasticity
FDA-2013-N-1152-0006Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2016-P-4093-0009Tab G -- Ferring Briefing Material NOCDURNA (January 12, 2015) (relevant excerpts) re…
FDA-2020-H-0216-0001Complaint
FDA-1976-N-0525-0145Soft Lenses, Inc. - Appearance Request
FDA-2011-N-0921-18608Reference 49 United Fresh Fruit and Vegetable Association. 2013. "Field Operations and…
FDA-2015-H-4634-0002Complaint
FDA-2022-H-0267-0001Complaint
FDA-2003-P-0123-0001HFA-305 to Faulding Pharmaceutical Company
FDA-2011-N-0921-18983QAR _Reference 158_NASPHV-2011-Compendium of Measures to Prevent Disease Associated with…
FDA-1997-S-0006-1422Courtesy Letter from CFSAN to Phytomatrix Natural Technologies
FDA-1989-E-0386-0007Syntex (U.S.A.) Inc. to U.S. Patent and Trademark Office - Correction (1)
FDA-2010-S-0664-1475FoodScience Corporation - Lipo Fade DaVinci Laboratories of Vermont - Support Lean Weight…
FDA-2025-P-1807-00158- Moderna Inc 2018 form S1 registration statement US securities and Exchange…
FDA-2024-N-5975-0001Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated…
FDA-2014-H-1481-0001Complaint
FDA-2019-N-3065-0727Reference 132 - A Meta-Analysis of the Relationship Between Environmental Tobacco Smoke…
FDA-2025-E-3942-0002Patent Extension Application from Sleman & Lund LLP (on behalf of Abbott Cardiovascular…
FDA-2017-H-1858-0001CMP Complaint Issued to First Coast Energy L.L.P. d/b/a Shell Food Mart
FDA-2009-S-0607-0395Perrigo - Target Up & Up Women's Menopause Support - Women's Menopause Support
FDA-2022-H-2281-0001Complaint
FDA-2022-S-0024-02432022-000231 - Indiana Botanic Gardens Inc.- Botanic Choice Horny Goat Weed- Supports…
FDA-2015-N-0002-0013FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA…
FDA-2007-D-0369-0835PSG_020121- Draft Guidance on Fluticasone Propionate
FDA-2022-V-3378-0001Variance Application from Judd Lacson
FDA-2008-D-0611-0001Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review…
FDA-2007-P-0189-0012Background Material re Acorda Therapeutics, Inc…
FDA-2016-H-4567-0001Complaint
FDA-2018-V-1614-0003WGC - Laser(1) re: Variance Application from KBW Design Ltd
FDA-1978-N-0018-1011Reference 170 - Marionnet_2014_Diversity of biological effects induced by longwave UVA1 in…
FDA-2015-P-1279-0020Citizen Petition from Cigar Rights of America
FDA-2016-H-3168-0001Complaint
FDA-2024-P-4935-0006Completeness Assessment Correspondence
FDA-2023-N-5302-0002NOOH letter from FDA ORA to Michael Dominic Diaz
FDA-1991-N-0025-0065BACKGROUND MATERIAL
FDA-2018-S-0024-07302018-5720 ProCaps Laboratories- Ultimate Friendly Flora- SUPPORTS DIGESTIVE AND IMMUNE…
FDA-2016-H-2407-0001Complaint
FDA-2022-P-0324-0004Response Letter from FDA CDER to Karl Schwartz
FDA-2000-N-0114-0002Cover Page - [Revisions of Certain Food Chemicals Codex Monographs, New General Test…
FDA-2022-H-1073-0001Complaint
FDA-2015-V-1124-0002Acknowledgement Letter from FDA DDM to Pro Tech
FDA-2012-N-0882-0036Presentation by James Polli, University of Maryland re GDUFA Public Meeting
FDA-1977-P-0017-0036Acknowledgement Letter from FDA/DDM to The Cosmetic, Toiletry & Fragrance Association…
FDA-2021-S-0024-07002021-001013 - Onnit - Onnit, Key Minerals 120c - Supports Total Body Health and Assists…
FDA-2021-V-0753-0003Variance Approval Letter from FDA CDRH to Corbin Schueller
FDA-2024-H-0785-0001Complaint
FDA-2025-P-1070-0007Completeness Assessment Correspondence
FDA-2000-N-0044-0054FDA to National Association of Hispanic Nurses (NAHN)
FDA-2025-V-5808-0003Variance Approval Letter to Roofdeck Entertainment LLC
FDA-2012-V-0400-0002Acknowledgement Letter to Lockheed Martin
FDA-2019-H-3380-0001Complaint
FDA-2021-V-1020-0002Acknowledgment Letter from FDA DMS to Meow Wolf Denver
FDA-2015-H-4032-0001CTP CMP Case re Chicken Express, L.L.C. d/b/a Kennedy Fried Chicken and Pizza
FDA-2016-P-2674-0004FDA CDER Response to Heritage Pharma Labs, Inc.
FDA-2009-V-0065-0001Colorado Sound N' Light, Inc. - Application for Variance
FDA-2021-S-0024-07232021-001060 - SmartyPants Vitamins- SmartyPants Organics Toddler Formula- SUPPORTS ENERGY
FDA-2019-H-2238-0001Complaint
FDA-2017-S-0023-0150NDI 1047 - DHA ethyl ester algal oil - Original NDI Notification
FDA-2017-H-2663-0001CMP Complaint Issued to S G Convenience and Smoke Shop, LLC d/b/a Pasco Road Convenience
FDA-2025-S-0024-06492025-000741 - Transformative Learning Pte. Ltd. - AYUTTVA, Clearizy Capsules - Helps keep…
FDA-2024-P-0545-0006Completeness Assessment Correspondence
FDA-2015-Q-4850-00092013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of…
FDA-2008-P-0531-0261Reference 1 - "FDA/CDRH Response Letter to Richard F. Edlich, March 9, 2010" - [Richard F…
FDA-1996-F-0131-0009Appendix B Letter from Phoenix Regulatory Associates, Ltd. to Witco Corporation, July 21…
FDA-2011-P-0573-0006R.J. Reynolds Tobacco Company (RJRT) - Supplement
FDA-2012-N-0841-0001ASTM International-Food and Drug Administration Workshop: Absorbable Medical Devices…
FDA-2021-S-0024-07392021-001077 - International Vitamin Corporation- MULTIPLE CLAIMS (20)
FDA-2022-V-3278-0003Variance Approval from FDA CDRH to DMGC Golf Management
FDA-2025-H-6440-0001Complaint
FDA-2013-D-1543-0207Memorandum of Meeting Amgen
FDA-2016-N-3389-003702-34 Review efficacy of alginate supplementation in relation to appetite regulation and…
FDA-2015-S-0024-0512Mindworks, Inc. - NeuroVite Plus - Formulated to enhance thinking, vision, and all the…
FDA-2005-P-0061-0003Letter from FDA CFSAN to Alaska Birch Syrupmakers Association
FDA-2012-N-0977-0007Agency Information Collection Activities; Proposed Collection; Comment Request…
FDA-2013-P-1505-0001Teva Respiratory, LLC (Teva) - Citizen Petition
FDA-2020-S-0024-01752020-000250 Phytomatrix Natural Technologies (British Columbia) Hemp For Life - Liver…
FDA-2006-N-0169-0003Environmental Assessment for Removing the Essential-Use Designation Under 21 CFR 2.125 for…
FDA-2022-V-0047-0002Acknowledgment Letter from FDA DMS to Holley Christian Church
FDA-2021-S-0024-08002021-000805 - EuroPharmaTerry NaturallyEuroMedica - EuroMedica; Zinc plus Selenium…
FDA-2009-P-0581-0010Exhibit I - "District of Kansas, Eastern District of Wisconsin, Norbrook Labs' Reply…
FDA-1997-S-0039-2440Perrigo - GoodSense - CENTURY - antioxidants important for maintaining healthy immune…
FDA-1986-G-0286-0024Letter from Fox, Bennett & Turner to FDA/HFS-217
FDA-2016-V-1208-0001Variance Application from 5 Diamond Productions
FDA-2014-N-0189-83066Reference 162 Peering Through the Mist re Deeming Tobacco Products To Be Subject to the…
FDA-2022-H-2296-0001Complaint
FDA-2016-N-3389-0035Reference 02-32 Dose-dependent suppression of hunger by a specific alginate in a…
FDA-2022-E-0936-0003Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-1987-N-0054-0286Application to Renew Motion to Strike from FDA CDER
FDA-2014-P-1753-0006Interim Response Letter from FDA CDER to Angela Stanton, Ph.D.
FDA-2014-N-0189-3083Request for Extension from Anonymous
FDA-2022-N-0072-0001Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange…
FDA-2001-M-0146-0002Petition Denial letter from FDA/CDRH to The TMJ Association
FDA-2025-E-1226-0001Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-1988-G-0204-0008Introduction re GRAS Affirmation Petition: Sorbitan Tristearate for Use Only in for…
FDA-2008-P-0116-0024FDA/CDER Interim Response to the Commissioner of Health, State of New York Department of…
FDA-2011-N-0012-0006Proyecto Informar; Hispanic Outreach Initiative
FDA-2016-D-2241-0332Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling…
FDA-2021-N-0403-0020Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2004-P-0342-0016HFS-820 to Whole Grains Council
FDA-2025-V-6830-0002Acknowledgment Letter from FDA DMB to Sitka EDM
FDA-2024-N-0017-0001Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing…
FDA-2016-V-1145-0001Variance Application from Michael Wandtke
FDA-2004-E-0267-0003U.S. Patent and Trademark Office to FDA/CDER (HFD-13)
FDA-1975-N-0012-0308FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
FDA-2014-E-0100-0006Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2024-H-4068-0001Complaint
FDA-2012-S-1144-0974Maximum Human Performance LLC - CARNIVOR MASS - Anabolic Beef Protein Gainer
FDA-2020-P-1443-0018Tab 17 Re: Citizen Petition from Elanco Animal Health
FDA-2016-H-4316-0001Complaint
FDA-2015-E-2582-0005Letter from U.S. Patent and Trademark Office to CDER
FDA-2007-D-0136-0003Number not Used
FDA-2008-D-0520-0015Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability
FDA-2017-H-2259-0001CMP Complaint Issued to Hy-Vee, Inc. d/b/a Hy-Vee
FDA-1999-P-1286-0005FDA/CVM to Humane Society - Letter
FDA-2024-E-3874-0005Letter to U. S. Patent and Trademark Office
FDA-2019-D-0661-15434Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed…
FDA-1980-F-0033-0002Indirect Food Additives: Polymers; Adjuvants, Production Aids, and Sanitizers
FDA-2000-N-0109-0132GCF-1
FDA-2015-N-3469-0193Nomination from Athenex
FDA-2005-N-0094-0015Electronic Request for Appearance for Melvin, Marsha
FDA-2018-H-2432-0001Complaint
FDA-2016-H-0427-0001CTP CMP Case re Food Lion, LLC d/b/a Food Lion 1047
FDA-2013-N-1524-0001Bulk Drug Substances that May be Used to Compound Drug Products, etc., Concerning…
FDA-2016-S-0024-0100Health Genesis Corporation - Biophix, Raw Whole Food Organic Bone Support 120 Organic…
FDA-2007-D-0369-0331FDA Overview of Biological Products re Comment from Vifor Pharma, Ltd
FDA-1997-S-0039-1806Perrigo Company of South Carolina-Century Mature Vitamin A-Vitamin A-
FDA-2015-E-4704-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2009-V-0139-0002Acknowledgement Letter to B. E. Meyers & CO., Inc.
FDA-2019-H-3563-0001Complaint
FDA-2024-H-1019-0001Complaint
FDA-2024-S-0024-03552024-001086 - Eversio Wellness Ltd. - Eversio Wellness, Focus Now - improves…
FDA-2023-V-1595-0003Variance Approval Letter from FDA CDRH to ARRI Americas Inc.
FDA-2016-V-0088-0003Variance Approval from FDA CDRH to David Synek
FDA-2009-P-0581-0007Exhibit F - "Hogan & Hartson Letter to Williams & Connolly LLP, December 4, 2008 (re…
FDA-2013-S-0024-0706Perrigo Company of South Carolina - Multiple Claims - 11
FDA-2023-H-0995-0001Complaint
FDA-1978-N-0020-0003Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical…
FDA-1997-S-0006-0230FDA/CFSAN to Enzymatic Therapy Inc
FDA-2024-H-3239-0001Complaint
FDA-2012-P-1043-0001Foley & Lardner LLP - Citizen Petition
FDA-2023-N-3902-1827Comment from Jeanne M. Dicke
FDA-2009-S-0607-1414Perrigo - Dolgencorp, LLC DG Health E - Protect Cell Membranes in the Nerves, Muscles, and…
FDA-1997-S-0006-1133New Century Company LET1133 Response From FDA/CFSAN - Courtesy Letter
FDA-2022-V-0134-0001Variance Application from Micah Dennis
FDA-2013-D-0258-0007Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and…
FDA-2023-H-3933-0001Complaint
FDA-2014-E-0309-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2023-P-0172-0001Citizen Petition from Keller and Heckman LLP on behalf of Lucy Goods, Inc
FDA-2003-N-0161-0015See FDA-2003-N-0161-0007
FDA-2017-H-2518-0001CMP Complaint Issued to Fiza Enterprise LLC d/b/a Mir Food Mart / Mobil Mart
FDA-1997-S-0039-1572Enzymatic Therapy, Inc. - Child Essence - This bioactive nutrient provides enhanced…
FDA-2020-P-1243-0002Acknowledgment Letter from FDA DMS to Varun Varada
FDA-2009-N-0247-0064The Senior Citizens League "Statement of S.Benton" [Public Meeting FDA Transparency Task…
FDA-2016-P-1026-0004Reference 1 - Guidance for Industry and CDRH Staff on Procedures for Class II Device…
FDA-2002-P-0253-0001Federal Register
FDA-2022-D-0235-0010Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics…
FDA-2019-H-5541-0001Complaint
FDA-2014-N-0189-8938Request for Extension from Anonymous
FDA-2024-V-0732-0003Variance Approval Letter from FDA CDRH to Porche' Advanced Systems
FDA-2025-H-0587-0001Complaint
FDA-2016-N-0002-0013Environmental Assessment of PEGylated bovine granulocyte colony stimulating factor (PEG…
FDA-2019-H-3047-0001Complaint
FDA-2024-D-1244-0004Reference 2 - Chemistry, Manufacturing, and Control (CMC) Information for Human Gene…
FDA-2015-H-3593-0001CTP CMP Case re ESS EN CY, LLC d/b/a Oregon City Shel
FDA-2011-S-0933-0194HGH Pharmaceuticals (PTY) Ltd., Sceletium Tortuosum Extract (Zembrin) re Section 4…
FDA-2017-D-0085-0003GUIDANCE -REFERENCE LIST re Best Practices for Convening a GRAS Panel: Guidance for…
FDA-2017-E-5693-0001Patent Extension Application for ZINBRYTA
FDA-2014-H-0881-0001Complaint
FDA-2010-S-0664-1243NBTY, Inc. - Arsenal Training Pack - The Revolutionary Science of Men's Health
FDA-1990-P-0322-0002Cosmetic, Toiletry & Fragrance Association (CTFA) - Citizen Petition
FDA-2018-P-3616-0009Acknowledgment Letter from FDA DDM to Suven Life Sciences Limited
FDA-2023-S-0024-09272023-002221 - Jarrow Formulas - Jarrow Formulas®, Ideal Bowel Support® - Supports…
FDA-2009-P-0423-0016Acknowledgement Letter to Graceway Pharmaceuticals, LLC
FDA-2022-P-3293-0001Citizen Petition from Lachman Consultant Services, Inc.
FDA-2009-P-0162-0003Attachment 2 - "PetMedicus Laboratories, Inc. Draft Package Insert and Bottle Labeling"…
FDA-2011-S-0932-2716Perrigo - H-E-B - H-E-Buddy - Provides 10 essential vitamins with iron, important for…
FDA-2024-H-4041-0001Complaint
FDA-2009-P-0597-0034Amendment from WilmerHale
FDA-2007-P-0063-0003Citizen Petition from Lachman Consultant Services, Inc.
FDA-2020-E-1279-0006Letter from U. S. Patent and Trademark Office to FDA CDER
FDA-2019-P-6100-0020Attachment V Shuren Letter re: Citizen Petition from American Association of Tissue Banks
FDA-2010-N-0621-0195Dr. Midthun to Counsel, June 20, 2011 - Letter
FDA-1997-S-0006-1088[LET1088] - FDA/ONLDS/CFSAN Response to Jarrow Formulas - Courtesy Letter
FDA-2016-H-3537-0001Complaint
FDA-2018-H-1277-0001Complaint
FDA-2009-N-0493-0002OMB Review, Executive Order 12866, Regulatory Policy Management Staff to the Division of…
FDA-2017-P-3486-0001Citizen Petition from BioMedEcon, LLC
FDA-2014-P-2168-0006Withdrawal from Lachman Consultant Services
FDA-1997-S-0039-2178Perrigo - Multiple claims - 10
FDA-1982-P-0018-0275Background Material
FDA-2017-H-5546-0001Complaint
FDA-2006-N-0107-0043Octagon Research Solutions, Inc. - Testimony
FDA-1983-M-0010-0011FDA/Office of Health Affairs to W. Gerald Rainer, M.D.
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FDA-2007-D-0369-1329PSG_013263 - Draft Guidance on Diazepam
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FDA-2016-H-3190-0001Complaint
FDA-2017-V-5945-0002Acknowledgement Letter from FDA DDM to American Rheinmetall Systems
FDA-2014-V-0291-0001Variance Application from House After Hours
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FDA-2017-H-1894-0001CMP Complaint Issued to Wakim Enterprises, Inc. d/b/a Shell
FDA-2014-S-0024-0338Valosun US Inc (Uroval manosa + enzymes) - Letter
FDA-2014-E-2357-0006Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2012-N-1210-1163Reference 202-Surgeon Bone Health and Osteoporosis re Food Labeling: Revision of the…
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FDA-2002-V-0410-0003Variance Response Letter from FDA CDRH to SMOKY MOUNTAIN OPRY
FDA-2014-N-1051-0782781 appendix-6g-environ-tipping-point-analysis-2014
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FDA-2018-N-4206-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Medical…
FDA-2013-V-0919-0001Geller Laser - Application for Variance
FDA-2001-N-0566-0004Agency Information Collection Activities; Announcement of OMB Approval; New Animal Drugs…
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FDA-2015-S-0024-0510Mindworks, Inc. - Restful Sleep - Brain and body renewal
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FDA-1997-S-0006-1770Courtesy letter and related material from CFSAN to Onbix Corporation
FDA-1975-N-0012-0174Citizen Petition from Cosmetic, Toiletry & Fragrance Association (CTFA) and Soap &…
FDA-2017-H-1263-0001CMP Complaint Issued to You Save LLC d/b/a Shell
FDA-2014-H-0046-0001Complaint
FDA-1990-G-0246-0052Bayer AG Pharma Report No. 11475 - GLP - Compliance Statement (January 19, 1983)
FDA-2006-E-0507-0005Determination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL…
FDA-2015-N-3037-00400036_R_IND79010_A0027_Status2_CSR_16-1-7_Randomization-Scheme
FDA-2022-E-0673-0001Letter from U.S. Patent and Trademark Office to FDA CDER
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FDA-2020-H-0790-0001Complaint
FDA-2017-H-5497-0001Complaint
FDA-2003-N-0040-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
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FDA-1991-N-0026-0015Background Material
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FDA-2014-N-0189-5784Request for Extension from J.M.
FDA-2006-N-0245-0004Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2017-H-5955-0001Complaint
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FDA-2024-H-4506-0001Complaint
FDA-2006-D-0297-0001Draft Guidance for Industry: Blue Bird Medicated Feed Labels; Availability
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FDA-2023-H-3612-0001Complaint
FDA-2018-H-2096-0001Complaint
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FDA-2002-D-0177-0001FDA
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FDA-2024-E-3589-0005Determination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDI
FDA-2014-D-1540-0002Draft Guidance for Industry on Migraine: Developing Drugs for Acute Treatment
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FDA-2025-H-0979-0001Complaint
FDA-2023-H-4907-0001Complaint
FDA-2024-E-0430-0005Letter to U.S. Patent and Trademark Office
FDA-1977-N-0002-0542Envelope re: Comment from Iowa Farm Bureau Federation
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FDA-2005-P-0004-0002State of Connecticut
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FDA-2012-V-0580-0002Acknowledgement Letter to DJ4U Corp.
FDA-2014-N-2244-0387Reference 20_40 CFR Part 152 re Final Environmental Impact Statement and Record of…
FDA-2016-H-1370-0001Complaint
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FDA-2015-E-2577-0001Patent Extension Application from Edwards Lifesciences PVT, Inc.
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FDA-1977-N-0002-1694Answer Letter from FDA to Comment from The Honorable J. Bennett Johnston, United States…
FDA-2016-N-3118-043211-12-2014_ANDA 202608 re: Mallinckrodt Pharmaceuticals; Proposal to Withdraw Approval of…
FDA-1990-S-0006-0045Statistical Report for September 2003
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FDA-2012-N-1210-0623Request for Extension from American Beverage Association (ABA)
FDA-2014-N-1051-0476475 7694105 RDC CRF Subject R4035_Redacted
FDA-2021-V-1337-0001Variance Application from Billy Robison
FDA-2010-E-0663-0006FDA/CDER to U.S. Patent and Trademark Office - Letter
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FDA-1984-N-0259-0285Exhibits G-112 thru 119a Documentary Evidence re: Motion of the Center for Drugs and…
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FDA-2024-V-1624-0003Variance Approval Letter from FDA CDRH to Ian Zielinski
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FDA-2021-V-1230-0001Variance Application from Calvary Baptist Church
FDA-2015-V-2961-0001Variance Application from Vine Church
FDA-2023-V-0285-0001Variance Application from ElfTech LLC
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FDA-2017-H-1567-0001CMP Complaint Issued to The Spinx Company, Inc. d/b/a Spinx 259
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FDA-2022-H-0326-0001Complaint
FDA-2014-H-1626-0001Complaint
FDA-2007-D-0369-2140PSG_020980 - Draft Guidance on Terbinafine Hydrochloride
FDA-1995-N-0200-0009Tab 11 - Reprogenesis L.P. - [Hyman, Phelps & McNamra, P.C] - Appearance Request
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FDA-2013-H-1408-0001Complaint
FDA-2015-V-2793-0002Acknowledgement Letter from FDA DDM to Center Stage Entertainment
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FDA-2015-N-0101-1222Econ Reference 20 - Centers for Disease Control and Prevention re Safety and Effectiveness…
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FDA-1994-G-0059-0021Internal Memorandum from FDA
FDA-1993-P-0434-0010Attachment 9 Legal Opinion Letter re: Citizen Petition from William Nelson
FDA-2011-P-0798-0002Acknowledgement Letter to Dr. S. Albert Edwards
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FDA-2022-P-1643-0242Tentative Response Letter from FDA CVM to Association for Truth in Pet Food
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FDA-2018-H-4307-0001Complaint
FDA-2023-N-4742-0006Letter from Covington & Burling, LLP on behalf of Phibro Animal Health Corporation…
FDA-2004-S-0571-0122NDI 213 - 2-aminoethanethiol (cysteamine) hydrochloride from Omega Bio-Pharma (U.S.A.) LLC
FDA-2016-H-2367-0001Complaint
FDA-2021-V-0715-0001Variance Application from SIGNALS AUDIO VIDEO INC
FDA-2022-P-1913-0004Footnote 2 re Citizen Petition from Siri and Glimstad LLP
FDA-2017-D-6146-0006Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based…
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FDA-2017-H-1048-0001CMP Complaint Issued to AK, Inc. d/b/a Tesoro 2 Go
FDA-2018-H-0986-0001Complaint
FDA-1982-N-0011-0072Background Material
FDA-2017-D-2462-0057Comment from Fidelis Pharmaceuticals, Inc.
FDA-2023-N-3902-1236Comment from Lisa Anne Wray
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FDA-2012-N-0253-0010Agency Information Collection Activities; Submission for Office of Management and Budget…
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FDA-2025-P-2526-0011Reference 9 - United Nations (UN) (1989). Convention on the Rights of the…
FDA-2014-N-0189-4920Request for Extension from Anonymous
FDA-2018-E-0072-0005Letter to U.S. Patent and Trademark Office from FDA CDER
FDA-1995-P-0016-0080Background Material in 94P-0390
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FDA-2023-H-3086-0001Complaint
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FDA-1978-N-0018-0849Reference 7 - FDA_Sunscreen- How to help protect your skin from the sun
FDA-1980-N-0038-0287Supplement from Center for Drugs and Biologics (CDB) (Vol. 7 of 15)
FDA-2022-H-1902-0001Complaint
FDA-2018-H-4620-0001Complaint
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FDA-2013-N-1524-2003Nomination Letter Leucine (L) USP re: Comment from Fagron
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FDA-2008-V-0375-0005Appendix 4 - Training CD and PowerPoint Presentation [Aribex - Application for Variance]
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FDA-2023-N-2177-7154FRIA Reference 38 - National Cancer Institute, "Cancer Stat Facts: Common Cancer Sites,"…
FDA-2000-N-0190-0054Reference 50 - "Memorandum from Food Animal Concerns (R.Wood) to FDA (L.Carson), August…
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FDA-2011-V-0892-0001The Boys DJ - Application for Variance
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FDA-2011-E-0682-0005Determination of Regulatory Review Period for Purposes of Patent Extension; YERVOY
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FDA-2007-P-0126-0001Acknowledgment Letter from FDA/DDM to Akorn-Strides, LLC
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FDA-2015-S-0024-0746Perrigo Company of South Carolina - Health Mart® - B12 - Helps support energy metabolism…
FDA-2003-N-0453-0001Training Program for Regulatory Project Managers; Information Available to Industry
FDA-2015-V-1020-0001Variance Application from Greg Deshong Redacted
FDA-2018-V-0195-0003Variance Approval Letter from FDA CDRH to ACOUSTIC-OPTICS
FDA-2010-S-0665-0153Bioberica, S.A., (INMUNACTIVE) re Annex III - "INMUNATIVE Oral Presentation Summary on the…
FDA-2017-S-0024-07092017000861 - International Vitamin Corporation - MULTIPLE CLAIMS (6)
FDA-1977-N-0014-0875Answer Letter from FDA to Comment from The Honorable Bill Proxmire, United States Senate
FDA-2006-P-0405-0011Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart…
FDA-2012-N-0560-0015Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2025-P-1143-0079List of Narcotic Drugs Under International Control
FDA-2013-D-1464-0016Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an…
FDA-2025-H-4395-0001Complaint
FDA-2005-D-0208-0005Reference 1 - FDA Blood Products Advisory Committee Meeting, March 1999…
FDA-2002-N-0323-0184Reference 4-11 CDC Tracking and Reporting Foodborne Disease Outbreaks re Amendments to…
FDA-2000-M-0177-0001Medical Devices; Availability of Safety and Effectiveness Summaries for PMA
FDA-2024-E-5279-0002Patent Extension Application from Foley & Lardner LLP (on behalf of Chugai Seiyaku…
FDA-2017-H-4547-0001CMP Complaint Issued to Shayona Krupa LLC d/b/a Oven Door Mini Market
FDA-2010-N-0210-0019Reference 9 - "Livsmedelsverket, National Food Administration, The Keyhole Symbol"…
FDA-2015-N-0101-0763Reference 13-2 - Product Labels in OTC Vol. 03 HCATFM Approve OTC Drug Review Info…
FDA-2019-H-4301-0001Complaint
FDA-2010-N-0181-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Threshold…
FDA-2019-H-2806-0001Complaint
FDA-1978-N-0018-0119Answer Letter from FDA/CDER to Nicholas J. Lowe
FDA-1988-G-0298-0013Section V Statement of Responsibility re GRAS Affirmation Petition for…
FDA-2024-H-2093-0001Complaint
FDA-2019-P-2998-0104Final Response Letter from FDA CDER to Southern Network on Adverse Reactions (SONAR)
FDA-2016-H-4453-0001Complaint
FDA-2014-V-0769-0003Variance Approval from FDA CDRH to Off The Chart Entertainment
FDA-2017-H-4877-0001CMP Complaint Issued to Park N Shop 8 LLC d/b/a Park N Shop
FDA-2011-S-0932-0222Letter from NBTY, Inc.
FDA-2004-P-0215-0021Attachment B - [Hill Dermaceuticals Inc. - Supplement] re FDA-2004-P-0215-0010
FDA-2009-P-0597-0025Tab 61/Exhibit 61 - "The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal…
FDA-2003-P-0364-0003Acknowledgement Letter to Abbott Laboratories
FDA-2008-P-0329-0007Sun Pharmaceuticals, Ltd Supplement Comment re FDA-2008-P-0329-0003
FDA-2010-F-0537-0005Finding of No Significant Impact (FONSI) for Seed meal of safflower, Carthamus tinctorius…
FDA-1998-N-0051-0051Attachment 1 Alka-Seltzer Plus (ASP) Products Requiring Extension of April 29, 2010…
FDA-1990-S-0006-0037Statistical Report for August 2003
FDA-1999-P-2921-0009Purdue Pharma L.P.
FDA-2014-S-0024-0870Perrigo Company (Equaline - Glucosamnie Chondroitin Complex) - Letter
FDA-1997-S-0006-1874Courtesy letter and related material from CFSAN to Research and production association…
FDA-2003-E-0324-0004FDA
FDA-2024-E-3873-0002Patent Extension Application from Bozicevic, Field & Francis LLP (on behalf of Geron…
FDA-1992-G-0275-0036Section 1/Reference 10 - Growers Agreement re Sugar Beet Fiber from Delta Fibre Foods
FDA-1987-N-0054-0191Certificate of Service re: Reply to Motion from FDA CDER
FDA-2018-N-2582-000903_Lindstrom_Labeling Issues
FDA-2023-S-0024-00252023-000026 - Blueroot Health- Fairhaven Health, Cal-Mag- Provides Calcium & Magnesium for…
FDA-2024-E-1292-0002Patent Term Extension Application for FILSUVEZ Patent No 9,827,214
FDA-2014-N-0189-5359Request for Extension from Anonymous
FDA-2015-S-0024-0934Perrigo Co - Meijer™ - Promotional - Meijer Vitamin B complex supports energy metabolism…
FDA-2012-V-0996-0001Porta Party DJ Entertainment - Application for Variance
FDA-2007-D-0369-0640Draft Guidance on Medroxyprogesterone Acetate - PSG_012541
FDA-2014-N-0189-6514Request for Extension from Anonymous
FDA-2022-V-0387-0002Acknowledgment Letter from FDA DMS to Texas Live
FDA-2023-P-4324-0002Acknowledgment Letter from FDA DMS to Fresenius Kabi USA, LLC
FDA-2011-N-0522-0003Effective Date Requirement for Premarket Approval for an Implantable Pacemaker Pulse…
FDA-2013-H-1032-0001Complaint
FDA-2014-N-0189-39022Request for Extension from Cigar Rights of America
FDA-2021-P-0267-0016Reference 16 - Brain lesions, obesity, and other disturbances in mice treated with…
FDA-2016-H-0104-0001CTP CMP Case re Pioneer Square Market, LLC d/b/a Pioneer Square Market/Saveway Market
FDA-1978-N-0022-0016External Analgesic Drug Products for Over-the-Counter Human Use; Amendment to Tentative…
FDA-2023-N-3902-1714Comment from Germaine Payne
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FDA-2011-N-0513-0008FDA/CDER to Margaret A. Hamburg, M.D. , FDA Commissioner - Response to November 7, 2011…
FDA-2024-H-1162-0001Complaint
FDA-2020-D-0957-007574-hysteroscopic-and-laparoscopic-insufflators-submission-guidance-510k
FDA-2014-N-2031-0001Request for Nominations on the Food Advisory Committee
FDA-1989-F-0343-0002Food Additives Permitted for Direct Addition to Food for Human Consumption; Sucrose Fatty…
FDA-2013-D-0068-0010International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals…
FDA-2011-E-0716-0005Determination of Regulatory Review Period for Purposes of Patent Extension; NOVOTFF–100A…
FDA-2014-N-1205-0002List of Reference re Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid…
FDA-2017-E-6698-0005Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS
FDA-2021-V-0819-0001Variance Application from Dalton Haynes
FDA-1991-P-0058-0001Lois M. Meyer - Citizen Petition
FDA-2013-H-1196-0001Complaint
FDA-2015-N-0101-0152Reference 7-143 - FDA-1975-N-0012-0081 -- C12 Ref - 141_Nahata 1985 re Safety and…
FDA-2018-V-1066-0003Variance Response Letter from FDA CDRH to Schwa Productions
FDA-2017-H-5388-0001Complaint
FDA-2007-V-0139-0001Acknowledgement Letter to Williamsville Space Lab Planetium
FDA-2024-N-2910-0091PRIA Reference 23 - Huang Cost Effectiveness Added Sugar Labeling 2019
FDA-2011-N-0103-0031Index to References FR
FDA-2003-E-0066-0007U.S. Patent and Trademark Office
FDA-2023-N-2177-7055Reference 205 - Comment to the Docket from American Society for Microbiology Re: Docket…
FDA-2016-S-0023-0146NDI 952 Bio-Androdia - REFERENCE LIST
FDA-2020-P-2247-0012Exhibit 3 re: Boehringer Ingelheim USA Corporation on behalf of Boehringer Ingelheim…
FDA-2015-V-1656-0003Approval for Variance from FDA CDRH to Ragerlazer Laser Shows
FDA-2018-P-3102-0017FMTVDM©℗ Stress-First/Stress-Only Imaging is here! But First We Need to Clarify the Use of…
FDA-2005-N-0296-0004Supporting Statement
FDA-2011-N-0002-0109Tobacco Products Scientific Advisory Committee
FDA-2009-V-0279-0003FDA/CDRH Response to Static Brigade - Approval for Variance
FDA-2018-N-4626-0066Nomination from Wedgewood Pharmacy
FDA-2017-H-1260-0001CMP Complaint Issued to Melvin E. Berrios David d/b/a El Romantico Bar and Restaurante
FDA-2014-N-0189-8296Request for Extension from Anonymous
FDA-1976-N-0476-0490Answer from FDA to Comment from Warner-Lambert Company
FDA-1991-G-0159-0010Reference 8 FDA, Novo Laboratories, Inc., Letter of Filing of Petition for Affirmation of…
FDA-2023-V-5073-0002Acknowledgment Letter from FDA DMS to John Bartlett
FDA-2025-V-1043-0003Variance Approval Letter from FDA CDRH to ISI Industries LLC
FDA-1995-N-0054-13772Background Material for NFR 1
FDA-2012-N-0001-0066Gastrointestinal Drugs Advisory Committee Meeting; Cancellation
FDA-2018-H-4008-0001Complaint
FDA-2016-N-3120-0101127_FDA Study Subject_Redacted
FDA-2007-N-0037-0007Agency Information Collection Activities; Proposed Collection; Comment Request; Animal…
FDA-2020-D-0957-0192192-Exemption-from-Certain-Reporting-and-Recordkeeping-Requirements-for-Microwave-Ovens
FDA-2019-E-5267-0002Patent Term Extension Application from Paratek Pharmaceuticals, Inc
FDA-2011-S-0932-0471Letter from NBTY, Inc.
FDA-1997-S-0039-1663Letter from Perrigo Company of South Carolina - Eye Health
FDA-2014-E-0130-0003Patent Extention Application from Protein Sciences Corporation
FDA-2020-E-1282-0007Letter from FDA CDER to U. S. Patent and Trademark Office
FDA-2013-N-1524-1979Nomination Letter Inositol re: Comment from Fagron
FDA-2019-S-0024-09552019-002748 - Nutranext LLC. - Neocell-Biotin Bursts 30ct - Supports healthy hair and…
FDA-2012-N-1210-1067Reference 127 Consumer Behavior Res re Food Labeling: Revision of the Nutrition and…
FDA-1998-N-0010-0002FDA
FDA-2016-D-4308-002806 Reference 5 AABB Standards for Blood Banks and Transfusion Services 30th edition
FDA-2022-S-0024-12112022-120 - Natural Factors- MULTIPLE (2)
FDA-2023-P-4616-0001Citizen Petition from Zydus Pharmaceuticals (USA) Inc.
FDA-2015-H-3769-0001CTP CMP Case re Checker’s II Inc. d/b/a Spirit
FDA-2013-N-0879-0009Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2006-P-0144-0007Background Materials re: Citizen Petition from Kirkpatrick & Lockhart Nicholson Graham…
FDA-1995-N-0054-13906Background Information to NPR1
FDA-2014-N-0998-0008Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2019-H-2761-0001Complaint
FDA-2017-H-6243-0001Complaint
FDA-2004-H-0391-0065FDA/CDRH/OGC
FDA-2013-N-0013-0203Reference 29 Food Safety Modernization Act, February 27, 2014 re Sanitary Transportation…
FDA-2003-N-0161-0043Exploring the Link Between Food Labeling and Weight Management
FDA-2007-D-0369-0294Tab 1 FDA Draft Guidance on Naltrexone re Comment from Alkermes Inc
FDA-2019-H-0659-0001Complaint
FDA-2010-D-0530-0041List of references - re Guidance for Industry: Considering Whether a Food and Drug…
FDA-2017-H-1194-0001CMP Complaint Issued to Diane M. Houser d/b/a 7 Eleven Store 28816A/2541
FDA-2022-H-2453-0001Complaint
FDA-2008-S-0664-0009NDI 426 - Hyaluronic Acid or Sodium Hyaloronate from Aquaflex, Inc.
FDA-2016-V-1142-0001Variance Application from ITI Manufacturing, Inc.
FDA-2024-S-0024-05872024-001430 - Harmony Foods LLC. - Rite Aid Women's Multivitamin Gummies 100ct- Support to…
FDA-2019-H-2299-0001Complaint
FDA-2025-H-4588-0001Complaint
FDA-2025-S-0024-10022025-001090 - Gaia Herbs Inc - Gaia Herbs, Adrenal Health Daily Support 120 Liquid…
FDA-1989-G-0391-0166References: Articles and Publications (Abstracts and Authors Russell-Salvers) re: Fifth…
FDA-2011-D-0489-0017Reference 1- Agency Nano Final Guidance-FINAL re Guidance for Industry Safety of…
FDA-1980-N-0038-0248Disclosure of Data and Information from Ciba-Geigy Corporation (Vol. 3 of 12)
FDA-2017-P-5082-0003Exhibit 1 Elysium Basis Summary Report re Citizen Petition from ChromaDex, Inc.
FDA-2022-N-2796-0002Response Letter from FDA CDER to Bristol Myers Products Inc.
FDA-2010-P-0642-0005Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc. - Supplement
FDA-2015-H-4140-0001CTP CMP Case re S.N.C., Inc. d/b/a Collette’s Mobil
FDA-2025-H-1567-0001Complaint
FDA-2009-P-0222-0004Acknowledgement Letter to PharmaForce, Inc.
FDA-1990-G-0246-0129JECFA Monographs & Determinations (Table of Contents)
FDA-2011-N-0915-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance…
FDA-2020-P-0725-0003Appendix 1 ENFit ISOSAF Single Use Syringe Example Labels re Citizen Petition from GBUK…
FDA-2014-H-1941-0001Complaint
FDA-1999-D-0011-0003Guidance for Industry Chemistry, Manufacturing, and Controls Changes to an Approved NADA…
FDA-2010-D-0350-0014Guidance for Tobacco Retailers on Tobacco Retailer Training Programs
FDA-2022-S-0024-14042022-001964 -TSI USA LLC - Tailored Script, Diindolylmethane
FDA-1975-N-0337-0004Supplement from PBM Pharmaceuticals, Inc.
FDA-2014-H-2149-0001Complaint
FDA-2015-P-1433-0069Interim Response Letter from FDA CVM to Mr. Michael Welber
FDA-2015-S-0024-2503Perrigo Company - Equate - promotional - Calcium is a primary mineral responsible for…
FDA-2009-P-0337-0002Acknowledgement Letter to Lachman Consultant Services, Inc.
FDA-1997-S-0039-1762Pharmavite LLC - Nature Made Sleep - Fall asleep naturally, wake up with no morning…
FDA-2010-S-0664-1297NBTY, Inc. - Natural Cranberry Fruit Concentrate - Promote Urinary Health
FDA-2009-E-0017-0009U.S. Patent and Trademark Office to Sidley Austin LLP - Notice of Final Determination and…
FDA-2015-E-0857-0004U.S. Patent and Trademark Office to CDER
FDA-2006-P-0013-0002Acknowledgement Letter from FDA DDM to Lupin Pharmaceuticals, Inc.
FDA-2010-S-0664-1381Vitacost.com, Inc. d/b/a Nutraceutical Sciences Institute - NSI Synergy GlucoPower…
FDA-1990-N-0007-0163Background Material
FDA-2007-D-0369-2274PSG_202292 - Draft Guidance on Crofelemer
FDA-2004-N-0057-0025Arkansas Department of Human Services
FDA-2011-S-0932-0782NBTY, Inc. (Healthy Accents Daily Multiple Supplements) Promotes Energy Metabolism…
FDA-2013-S-0024-0627NBTY - Prenatal Multi supplements - the healthy development of your growing child
FDA-2011-S-0932-0674Letter from Highland Laboratories
FDA-1982-P-0018-0230Background Material
FDA-2016-H-4528-0001Complaint
FDA-2018-N-4626-0100Nomination from Wedgewood Pharmacy
FDA-2023-N-3902-1334Comment from Access Living
FDA-2012-S-1144-0238Vitacost.com, Inc. - Vitacost Ultra 357 Energy Complex - 100% natural, stimulant-free…
FDA-1978-N-0018-15901PASS Coalition Letter to FDA re CDER Meeting on Sunscreen Ingredients
FDA-2015-S-0024-2624NBTY - Vitamin E supplements under the Finest label - Antioxidant health
FDA-2023-V-2539-0002Acknowledgment Letter from FDA DMS to Kls Solutions
FDA-2025-V-0475-0003Variance Approval Letter from FDA CDRH to Patrick R. Tolloti
FDA-2006-S-0544-0177NDI 364 - Clematis mandshurica Rupr. from SK Chemical Co., Ltd.
FDA-2017-S-0024-05112017000644 - International Vitamin Corporation - Member's Mark 400 mg Maximum Strength…
FDA-2023-V-5067-0001Variance Application from Mountain of Entertainment Theater
FDA-2019-H-1887-0001Complaint
FDA-2016-P-1247-0003Interim response from CDER to KVK-Tech, Inc
FDA-2024-E-1743-0002Patent Extension Application from Boehringer Ingelheim Animal Health USA Inc. (on behalf…
FDA-2001-P-0128-0001HFZ-1 to Bio-Rad Laboratories
FDA-2017-H-2727-0001CMP Complaint Issued to Tuti’s LLC d/b/a Tuti’s Food Mart
FDA-2024-N-5468-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2023-H-0372-0001Complaint
FDA-1978-N-0022-0007External Analgestic Drug Products for Over-the-Counter Human Use Establishment of a…
FDA-2023-H-1033-0001Complaint
FDA-2025-H-2407-0001Complaint
FDA-2025-P-1020-0002Acknowledgment Letter from FDA DMB to Hannah Boudreaux
FDA-2017-H-3481-0001CMP Complaint Issued to Community Mini-Markets Inc. d/b/a Community Mini Markets
FDA-2023-N-0155-0033R1 CDC Overweight and Obesity 042023
FDA-2007-D-0369-0813PSG_211230 - Draft Guidance on Solriamfetol Hydrochloride re Product-Specific Guidances…
FDA-2020-M-1868-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2011-V-0894-0002Acknowledgement Letter to Hypnotix Entertainment
FDA-2016-E-1298-0002Letter from U.S. Patent and Trademark Office
FDA-2006-O-0057-0053Request for Framework for Review from Covington & Burling LLP to FDA CDER
FDA-2023-V-2751-0001Variance Application from Paradox Production Design
FDA-2005-P-0131-0001HFA-305 to Kalsec Inc.
FDA-1991-N-0033-0011FDA
FDA-2014-N-0189-5277Request for Extension from Anonymous
FDA-2004-P-0525-0002Acknowledgement Letter from FDA DMB to Frito-Lay, Inc.
FDA-2003-D-0435-0023See FDA-2007-0487
FDA-1987-V-0013-0014Request of Extension of Compliance Date from Benedum Natural Science Theater
FDA-1992-P-0494-0001FDA/CDER to Birth Defect Research for Children, Inc. - Denial of Petition
FDA-2017-H-3695-0001CMP Complaint Issued to Minit Serve Dairy, Inc. d/b/a Minit Serve Dairy
FDA-2020-E-1328-0006Determination of Regulatory Review Period for Purposes of Patent Extension; Smallpox and…
FDA-2014-N-0189-5083Request for Extension from Anonymous
FDA-2020-V-2178-0001Variance Application from Albrecht Kohler
FDA-2011-S-0932-2699Prime Sources Supply LLC. - Naturo Kidniy Health and Naturo Diabiy Health
FDA-2024-P-1988-0002Acknowledgment Letter from FDA DMS to HealthyWomen
FDA-2015-S-0024-0819Matrixx Initiatives, Inc. - Zicam ® Total Immune Orange Burst Flavor Melts - Immune+…
FDA-1994-P-0127-0002Acknowledgement to United States Tuna Foundation
FDA-2007-P-0055-0006Letter from FDA CDER to Pharmaceutical Scientist Inc
FDA-2012-F-0949-0001Filings of Food Additive Petitions (Animal Use): Arcadia Biosciences,Inc.
FDA-2016-S-0024-0548Flora, Inc - Udo's Choice Adult's Probiotic, a Dietary Supplement - It helps support…
FDA-2025-S-0024-09602025-001039 - Organika Health Products Inc - Bee Propolis - immune support
FDA-2009-N-0592-0070Reference List, (References 1-16) - [Informed Consent Elements; Final Rule] re…
FDA-2014-N-0189-8564Request for Extension from Anonymous
FDA-1987-N-0054-0217Certificate of Service
FDA-1992-S-0039-0011CDER to the Division of Dockets Management Orphan-Drug Designation Requests Memo 33…
FDA-2004-N-0188-0034Use of Materials Derived From Cattle in Human Food and Cosmetics - Interim Final Rule and…
FDA-2020-P-1236-0003Attachment 1 re: Citizen Petition from Foley & Lardner LLP
FDA-2023-N-3902-0250Comment from Carolyn Heath
FDA-2013-N-0080-0017Acceptance of Clinical Data to Support Medical Device Applications and Submissions…
FDA-2025-H-0539-0001Complaint
FDA-1997-S-0039-1789Perrigo Company of South Carolina - Western Family®- Magnesium, CareOne® - Magnesium…
FDA-2019-H-2907-0001Complaint
FDA-2020-P-2066-0001Citizens Petition from The America's Frontline Doctors
FDA-2024-H-4881-0001Complaint
FDA-2011-N-0656-0023Animal Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment…
FDA-2019-H-1775-0001Complaint
FDA-2024-E-5280-0004Letter from U. S. Patent and Trademark Office to FDA CDER
FDA-1982-P-0018-0307Background Material
FDA-1989-F-0156-0003Memorandum from Environmental Impact Section
FDA-2019-H-4930-0001Complaint
FDA-2023-E-3238-0006Determination of Regulatory Review Period for Purposes of Patent Extension; LUNSUMIO
FDA-2013-N-0825-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2005-P-0120-0004Shire Pharmaceuticals Group - Citizen Petition
FDA-2014-S-0024-0374Perrigo Company (Health Mart - Complete) - Letter
FDA-2020-P-0863-0128Reference 112 Downey et al., 2019 re: Qualified Health Claim Petition from Sevo…
FDA-2021-V-0830-0001Variance Application from Dowebenasty
FDA-2010-S-0664-2414Perrigo - H-E-B Multiple Vitamins - Physical Energy, Mental Energy, Immunity, Joints and…
FDA-2010-P-0614-0061West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement
FDA-2024-V-5333-0001Variance Application from Hunter Zuniga
FDA-2018-H-2781-0001Complaint
FDA-1994-P-0028-0041Attachment 3 U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc, V…
FDA-2007-D-0369-1200PSG_017735 - Draft Guidance on Ethinyl Estradiol; Norethindrone
FDA-2007-E-0104-0002FDA/CDER to the USPTO- Letter
FDA-2014-N-0189-6701Request for Extension from Anonymous
FDA-2016-S-0024-1447USPlabs - MaxReps - Exercise Performance
FDA-1987-N-0054-0113Exhibit G-188.15-188.16 re: Disclosure of Data and Information from FDA CDER (Vol 104 of…
FDA-2010-P-0176-0038FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff…
FDA-2015-H-0069-0001Complaint
FDA-2020-S-0024-04602020-000580 VIT-BEST NUTRITION INC - Body & Soul Vitamin A 2,400mcg RAE - Supports a…
FDA-2017-S-0024-0212Himalaya Drug Company- Multiple Claims ( 36) - 1 - Curcumin Complete -The Joint Solution…
FDA-2011-S-0932-0265Letter from NBTY, Inc.
FDA-1997-S-0039-0896Perrigo Company of South Carolina - HEB®-Folic Acid - Folic Acid is essential for the…
FDA-2024-H-3217-0001Complaint
FDA-2018-H-2516-0001Complaint
FDA-2023-N-3902-0803Comment from James Gardner
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FDA-1977-N-0002-1058Answer Letter from FDA/Office of Legislative Services to Honorable Floyd K. Haskell…
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FDA-2019-P-2853-0003Interim Response Letter from FDA to Fresenius Medical Care North America
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FDA-2017-S-0024-04312017-5140 NSE Products, Inc - MULTIPLE CLAIMS (2)
FDA-1993-G-0218-0080Part L-4 : Section I - Chemical Identity for Oat Fiber and for Hydrogen Peroxide…
FDA-2019-H-4857-0001Complaint
FDA-2014-N-0189-35455Request for Extension from Anonymous
FDA-2010-N-0001-0009Risk Communication Advisory Committee; Notice of Meeting
FDA-2016-E-3341-0007Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2011-V-0873-0001PMMG, Inc. - Application for Variance
FDA-2009-D-0568-0011Guidance for Industry; Planning for Effects of High Absenteeism to Ensure Availability of…
FDA-2019-H-3625-0001Complaint
FDA-2016-H-2854-0001Complaint
FDA-2010-S-0664-0660Healthy Solutions, LLC. - Cider Vinegar 300 mg - Weight Management
FDA-1975-N-0248-0125Answer from FDA/OC to Honorable William B. Saxbe re Comment from Interstate Folding Box…
FDA-1975-N-0012-0357FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
FDA-2019-H-2629-0001Complaint
FDA-2012-F-0178-0001Sadex Corp.; Filings of Food Additive Petitions (Animal Use); Electron Beam and X-Ray…
FDA-2016-H-1602-0001Complaint
FDA-2015-S-0024-3092Waterpure, Inc. d/b/a Purity Products - OJC Daily Superfood Organic Juice Cleanse…
FDA-1977-N-0028-0008Tab 9: Jacobson, K. H., E. B. Hackley, and L. Feinsilver, "The Toxicity of Inhaled…
FDA-2021-D-1146-0041Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and…
FDA-2010-S-0665-0084Agency Response Letter GRAS Notice No. GRN 000112 re NDI 643, Avovida: Phytosterols from…
FDA-2017-D-0198-0005Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention…
FDA-2004-P-0214-0009References for Citizen Peition Response
FDA-2004-P-0097-0003Citizen Petition Denial from FDA CVM to Smart Drug Systems, Inc
FDA-2005-P-0329-0008Letter from Camargo Pharmaceutical Services to FDA CDER
FDA-2014-H-2162-0001Complaint
FDA-2019-N-1215-0002Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket…
FDA-1995-P-0051-0004Acknowledgment Letter from FDA DMB to Public Citzen Health Research Group
FDA-2019-H-5763-0001Complaint
FDA-2006-V-0098-0006FDA/CDRH to N9NE Group dba Moon Bar - Variance Attachment B
FDA-2023-V-2535-0002Acknowledgment Letter from FDA DMS to Vnc Lighting Systems
FDA-2013-S-0024-0006NutritionExpress Lindberg Astaxanthin 4 mg Letter
FDA-2001-D-0042-0001FDA
FDA-2005-N-0463-0002Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop…
FDA-2017-P-6922-0001Citizen Petition from Haynes and Boone, LLP
FDA-2010-S-0664-2604Perrigo - CareOne Daily Prenatal Combo - Deliver Oxygen to the Fetus
FDA-2018-H-3322-0001Complaint
FDA-2012-P-1155-0003Deka Research & Development Corp. - Supplement
FDA-2014-N-0189-4782Request for Extension from Anonymous
FDA-2017-S-0024-08712017001041 - International Vitamin Corporation - Walgreens Green Tea Caplets, 100 ct…
FDA-2015-N-3469-0184Nomination from Outsourcing Facilities Association
FDA-2023-N-1554-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2018-P-1068-0005Attachment3_C - FINAL Welgus Decl_ with exhibits - re Citizen Petition from Spear…
FDA-2021-V-0681-0001Variance Application from Further Interfaces LLC
FDA-1980-N-0038-0083Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus…
FDA-2005-P-0206-0002Acknowledgment Letter from FDA DDM to Morton Grove Pharmaceuticals, Inc.
FDA-2010-S-0664-2218Perrigo - Kroger Complete Active Performance - Energy Metabolism
FDA-1984-N-0259-0274Certificate of Service re: Motion of The Center for Drugs and Biologics to Supplement…
FDA-2023-E-3260-0007Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2002-N-0196-0002FDA
FDA-1997-S-0039-2012Wellness & Nutrition India Pvt Ltd. - Healthy Heart - Condition specific nutrition for…
FDA-2012-S-1144-1031NBTY, Inc. - Omega 3-6-9 - Supports Heart Health
FDA-2012-E-0019-0005Determination of Regulatory Review Period for Purposes of Patent Extension; NULOJIX
FDA-2017-P-0052-0010Reference 4 DSRResearchDonorsWhoAreOpen2015 re Citizen Petition from Donor Sibling…
FDA-2022-E-0275-0006Letter to U.S. Patent and Trademark Office
FDA-2019-P-5535-0001Citizen Petition from Foley & Lardner LLP
FDA-2018-H-4071-0001Complaint
FDA-1977-N-0002-1529Answer Letter from FDA/Commissioner of Food and Drugs to Honorable James B. Allen, United…
FDA-2023-N-0363-0002PFDD for Long COVID Discussion Questions English
FDA-2021-V-0049-0003Variance Approval Letter from FDA CDRH to Stacktrace Music, LLC
FDA-2024-H-3221-0001Complaint
FDA-2018-H-1942-0001Complaint
FDA-2020-P-1421-0001Citizen Petition from Encore Dermatology, Inc.
FDA-2016-S-0024-0656NBTY - B Complex supplements - Energy metabolism
FDA-2024-E-0477-0002Patent Term Extension Application for XACDURO® (sulbactam for injection; durlobactam for…
FDA-2016-P-3426-0003Exhibit 1 Letter from Inwood Pharmacy to Novitium Pharma LLC re Citizen Petition from…
FDA-2012-D-0049-0026AgencyInformation Collection Activities; Proposals, Submissions, and Approvals: Reporting…
FDA-1975-N-0012-0413FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
FDA-2020-D-0957-0142142-Sterilized-Convenience-Kits-for-Clinical-and-Surgical-Use
FDA-2003-E-0459-0007FDA/CDER to the USPTO - Letter
FDA-2019-P-5191-0013Appendix 11 Presentation Minor Components to Determine Oil Authenticity-2 re: Citizen…
FDA-2024-V-5051-0003Variance Approval Letter from FDA CDRH to GriGmusic LLC
FDA-2016-S-0024-2087Church and Dwight Co Inc - vitafusion™ Men's Complete Multivitamin - Powers Cellular…
FDA-2019-V-4213-0003Variance Approval Letter from FDA CDRH to LED Pro Solutions
FDA-2016-H-1296-0001Complaint
FDA-2015-E-1665-0004Letter from U.S. Patent and Trademark Office to FDA
FDA-1995-N-0054-13473Background Material for NFR 1
FDA-1978-N-0018-0370FDA
FDA-2024-H-1475-0001Complaint
FDA-2017-H-5381-0001Complaint
FDA-2003-E-0325-0003HFD-005 to U.S. Patent and Trademark Office
FDA-2020-V-1534-0002Acknowledgement Letter from FDA DMS to Show & Tell AV Solutions
FDA-2011-S-0932-0678Letter from Highland Laboratories
FDA-2016-P-2029-0001Citizen Petition from Buchanan Ingersoll & Rooney PC (Virtus Pharmaceuticals OpCo, LLC)
FDA-2014-N-1051-0425424 7694105 RDC CRF Subject R3016_Redacted
FDA-1987-N-0054-0327Certificate of Service re: Response to Warner- Lambert's Exceptions to the Initial…
FDA-2025-N-0418-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2011-P-0267-0004Determination That NIMOTOP (Nimodipine) Capsules, 30 Milligrams, Was Not Withdrawn From…
FDA-2017-N-4301-0050Developing a Software Precertification Program Challenge Questions April 2018
FDA-2016-N-2462-0011Reference 9 Parlodel re Amendments to the Regulation Regarding the List of Drug Products…
FDA-2016-D-3338-0001Guidance for Compliance Policy Guide Sec.150.200 Compliance Review of Private Laboratory…
FDA-2008-N-0038-0020Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting
FDA-2024-V-0665-0002Acknowledgment Letter from FDA DMS to Turner Imaging Systems Inc.
FDA-2022-E-2193-0006Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS…
FDA-2012-V-1139-0001SMR Media- Application for Variance
FDA-2004-P-0342-0002HFA-305 to Patton Boggs LLP
FDA-2022-H-2504-0001Complaint
FDA-2006-N-0309-0006Supporting Statement for General Licensing Provisions; Biologics License Application…
FDA-2019-S-0024-00512019002016- International Vitamin Corporation- up&up Men 50+ Multivitamin Multimineral…
FDA-2017-H-0777-0001CTP CMP Complaint to Claudio D. Rodriguez dba Willard St. Grocery
FDA-2015-N-0101-0432Reference 11-205 - FDA-1975-N-0012-0214 --- EMC12 GOJO_Industries_Inc_Comment re Safety…
FDA-2020-V-1765-0001Variance Application from Colin Kenyon
FDA-2024-H-5292-0001Complaint
FDA-2019-P-5403-0006Attachment 4 - Draft FDA Guidance Clindamycin_Phosphate_SOLUTION re Citizen Petition from…
FDA-2015-S-0024-2597NBTY - Green Tea Extract supplements - Promotes antioxidant support
FDA-2021-N-1309-0336PRIA Reference 24 NSDUH data tables 2019
FDA-1994-N-0094-0001Drug Export; Colestid (Colestipol Hydrochloride) 1-Gram Tablets
FDA-2017-N-4180-0002Request for Extension from Advanced Medical Technology Association (AdvaMed)
FDA-2007-N-0214-0054National Alliance on Mental Illness (NAMI) - Testimony
FDA-1980-N-0038-0218Vioform Hydrocortisone Hearing (Vol 31 of 34)
FDA-2013-N-0260-0008Enclosure 2 September 10, 2013 Letter re Letter from the Compressed Gas Association and…
FDA-2023-V-4780-0001Variance Application from Electronic Custom Distributors Inc.
FDA-2008-S-0663-0102Gingko Biloba-24% Leaf Extract, Lactones
FDA-2018-H-3828-0001Complaint
FDA-2016-P-3070-0006Appendix Table 2b - POSTPRANDIAL GLUCOSE CONTROL - Human Clinical Studies with Soy Fiber…
FDA-2016-V-2795-0002Acknowledgement Letter from FDA DDM to Theo Petrides
FDA-2023-H-2083-0001Complaint
FDA-2008-P-0411-0002Acknowledgement Letter to Caraco Pharmaceutical Laboratories, Ltd.
FDA-2008-N-0474-0016Volume 10 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re…
FDA-2003-N-0045-0005See FDA-2003-N-0045-0085
FDA-2014-N-0189-3192Request for Extension fromAnonymous
FDA-2007-D-0369-1599PSG_203993 - Draft Guidance on Clobazam
FDA-2024-H-4809-0001Complaint
FDA-2024-V-1872-0003Variance Approval Letter from FDA CDRH to Atomic Pro Audio
FDA-2016-S-0024-1174Perrigo Company of South Carolina - Meijer™ - Melatonin - Sleep Support
FDA-2007-P-0115-0002CDRH to Clinical and Laboratory Standards Institute
FDA-2007-D-0209-0023Agency Information Collection Activities; Proposals, Submissions, and Approvals
FDA-2020-N-1584-0011Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability
FDA-2017-H-6117-0001Complaint
FDA-1982-N-0011-0141Background Material
FDA-2005-E-0310-0009Exhibit C - Transmittal Letter [FDA-2005-E-0310-0006]
FDA-2022-S-0024-14562022-002032 - Blueroot Health - Fairhaven Health, Maca - encourage optimal hormonal…
FDA-2009-E-0072-0007FDA/CDER to US Patent and Trademark Office - Letter
FDA-2007-P-0463-0072Telephone Conversation between FDA and GMA/FPA
FDA-1990-N-0033-0032Background Material
FDA-1979-P-0017-0001Letter from FDA/CDER to Compressed Gas Association, Inc.
FDA-2008-D-0096-0029Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for…
FDA-2023-E-3296-0003Letter from FDA CDER to U. S. Patent and Trademark Office
FDA-2019-V-0658-0006Variance Approval Letter from FDA CDRH to Conti Temic Microelectronic GmbH
FDA-2016-D-1504-0001Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance…
FDA-2023-N-3902-1208Comment from Alicia Lippman
FDA-2017-H-1563-0001CMP Complaint Issued to Yousuf, Inc. d/b/a Shell
FDA-2015-S-0024-2392NBTY, Inc. - Vegetarian Omega 3-6-9 - Supports heart and circulatory health
FDA-2011-P-0604-0002Acknowledgement Letter to Public Citizen Health Research Group
FDA-2011-P-0924-0003Actavis, Inc. - Amendment
FDA-2005-P-0198-0004Citizen Petition from Perricone Juices
FDA-1990-G-0246-0213Appendix 5 Letter of "United States Department of Agriculture" February 1, 1993
FDA-2024-H-3089-0001Complaint
FDA-2010-E-0039-0003FDA/CDER to US Patent and Trademark Office - Letter

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