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Regulations.gov documents

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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2021-P-1248-0001.

FDA-2025-S-0024-15762025-001699 - New Generation Wellness Inc. - Marine Collagen Powder - Supports Healthy…
FDA-2003-P-0184-0002Acknowledgment Letter from FDA DMB to Russel J. Thomsen, M.D.
FDA-1997-S-0039-2703Perrigo Company of South Carolina - Hannford-Dairy Aid- Helps to prevent by breaking down…
FDA-2023-H-2661-0001Complaint
FDA-2007-D-0369-1158PSG_216578 - Draft Guidance on Fezolinetant
FDA-2014-N-0189-57918Request for Extension from Anonymous
FDA-2016-H-3701-0001Complaint
FDA-2010-D-0605-0003Reference 1 - FDA. Guidance for Industry: Product Recalls, Including Removals and…
FDA-2001-M-0110-0001Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2025-S-0024-1250025-001342 - Harmony Foods LLC. - CVS Sleep Support Gummies 50ct - Support Sleep
FDA-2004-N-0250-0004Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-1996-P-0246-0024Withdrawal of Certain Proposed Rules and Other Proposed Actions
FDA-2005-P-0437-0006Attachment 3 Approved Drug Products with Therapeutic Equivalence Evaluations 24th Ed…
FDA-2018-P-3284-0024Acknowledgment Letter from FDA DDM to Hogan Lovells US LLP
FDA-2014-N-0189-10769Request for Extension from Anonymous
FDA-2024-N-5471-0612Reference 610 Smith Mouth Level Nicotine Intake Estimates 2020
FDA-2012-S-1144-0845Dee Cee Laboratories, Inc. - Number 31 Stress Plus - Nutritionally Supports Energy…
FDA-2025-P-2109-0004Attachment 2 - CP - Summary Argument. Petitioners.
FDA-1997-P-0232-0007Calorie Control Council to FDA/CFSAN - Letter
FDA-2016-S-0024-0877OLLY PBC - Solid Bones - For strength and density
FDA-1995-P-0016-0124Background Material in 94P-0390
FDA-1977-N-0002-1505Answer Letter from FDA to Comment from J. Edward McCaffrey
FDA-2023-A-1640-0009Final Response Letter from FDA CDER to C. Humphrey & Associates
FDA-1984-G-0174-0054Pathogenicity and Exotoxin Studies with F. Arborescens: Toxicology Department Protocol…
FDA-2015-N-1765-0046Reference 44 - 2010 Meeting Materials of the General and Plastic Surgery Devices Panel
FDA-1997-S-0039-1107Enzymatic Therapy, Inc. - Panax Ginseng - You feel the difference right away. The benefits…
FDA-2021-S-0024-05932021-000899 - Urban Remedy- Urban Remedy Booster Shot- support immunity.
FDA-2016-S-0024-0154Health Genesis Corporation - Biophix, Vitamin D-3 5,000 IU 120 Organic Capsules - Biophix…
FDA-2016-H-4575-0001Complaint
FDA-2017-N-4179-0009Transcripts (Final) CardiacTroponinAssaysWorkshop_PDFTran
FDA-2024-N-5471-0708PRIA Reference 39 Centers for Disease Control National Youth Tobacco Survey 2020
FDA-2011-S-0932-2429Perrigo - Safeway - One Daily - Heart Health with Vitamins B6, B12, C, E and Folic Acid
FDA-2008-P-0638-0014FDA/CDRH Interim Response to Genentech, Inc. - Letter
FDA-1993-F-0429-0010Finding of No Significant Impact for FAP #3B4363 PPG Industries, Inc.
FDA-2013-D-0221-001304 - Final Guidance for Industry_Formal Dispute Resolution Sponsor Appeals Above the…
FDA-1997-S-0006-0001Indiana Botanic Gardens, Inc. (Folic Acid Tablets) LET695 Response From FDA/CFSAN…
FDA-2004-S-0530-0008Draft Pandemic Influenza Preparaedness and Response Plan (Core Document) - HHS…
FDA-2014-F-0988-0001BASF Corporation Filing of Food Additive Petition Animal Use
FDA-2018-H-2106-0001Complaint
FDA-1975-N-0012-0643Draft Protocol for Hormonal Effects Studies: Uterotrophic Bioassay of Benzethonium…
FDA-2015-N-3469-0320Nomination from Wells Pharmacy Network
FDA-2018-E-4431-0004Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2011-S-0932-2350Blue Sky Herbal, Inc. - Blood Sugar Support - Helps support normal blood sugar levels when…
FDA-1999-V-4083-0007FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance
FDA-2015-M-1557-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2022-N-2335-0001Prescription Drug User Fee Act VII; Independent Assessment of Communication Through…
FDA-2019-H-3203-0001Complaint
FDA-2014-V-1392-0004Variance Approval from FDA CDRH to LADY LIGHT LLC
FDA-2015-S-0024-1681Perrigo Company of South Carolina - Multiple Claims - 3
FDA-2020-V-1329-0004Letter from FDA CDRH to Avidex Industries, LLC
FDA-2023-E-3305-0002Patent Extension Application from Wei & Sleman LLP (on behalf of St. Jude Medical, LLC)
FDA-2023-H-4750-0001Complaint
FDA-1989-P-0008-0003HFA-305 to Intermedics Orthopedics, Inc.
FDA-2012-N-0386-0008Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2008-N-0448-0014Attachment 11 - National Forensic Laboratory Information System (Year 2006 Annual Report)…
FDA-2018-D-4367-0015Bioavailability Studies Submitted in NDAs or INDs—General Considerations; Guidance for…
FDA-2021-V-0149-0001Variance application from Grand Sierra Resort
FDA-2005-P-0367-0002Acknowledgment Letter from FDA DDM to Foley & Lardner LLP
FDA-1992-V-0023-0003Acknowledgement Letter from FDA to Mobile Laser Shows
FDA-2019-E-1942-0008Letter from FDA to U.S. Patent and Trademark Office
FDA-2018-H-1462-0001Complaint
FDA-2021-N-1349-0004Reference 1 HHS The Health Consequences of Smoking 50 Years of Progress 2014
FDA-2006-P-0455-0005Cover Letter - [Center for Science in the Public Interest (CSPI) - Citizen Petition]
FDA-1997-S-0039-0391[LET267] - Naturalife Corporation - Letter
FDA-2018-N-0236-001006 - Reference 5 - FDA's guidance Collection of Race and Ethnicity Data in Clinical Trials
FDA-2011-S-0932-2530McLind Corporation - Lindberg® Chromium Picolinate 200 mcg - Metabolism Support
FDA-2021-N-1309-0123Reference 120 NCI The Role of the Media in Promoting Monograph 19 2008
FDA-2013-P-0170-0001Clinipace Worldwide - Citizen Petition
FDA-2023-V-3997-0002Acknowledgment Letter from FDA DMS to Ascend Productions
FDA-2015-N-0101-0704Reference 12-143 - FDA-1975-N-0012-0237 --- CP13 75n-183h_cp00013_019_Tab_018_vol126 re…
FDA-2025-S-0024-09292025-001006 - Comfort Click Limited - WeightWorld, Vitamin D3 4000IU-400 Tablets - Bone…
FDA-2022-V-2966-0003Variance Approval Letter from FDA CDRH to Trident Military Systems LLC
FDA-2023-P-1847-0002Acknowledgment Letter from FDA DMS to Orion Corporation, Orion Pharma
FDA-2014-N-0053-0113PRIA Reference 30 - Eastern Research Group 2020 - Recall cost case studies RE Requirements…
FDA-1986-G-0007-0019Report 10 Maltitiol GRAS Affirmation Petition re Citizen Petition from Towa Chemical…
FDA-2015-H-4581-0001CTP CMP Case re Sideth Patel d/b/a GasKwick
FDA-2014-D-1167-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2007-D-0369-0916PSG_216227 Draft Guidance on Chloroprocaine Hydrochloride
FDA-2013-S-0024-0349Perrigo Company (Equate - Promotional) - Letter
FDA-2012-S-1144-1595Perrigo Company of South Carolina - Target Up & Up - Fish Oil - supports eye, brain and…
FDA-2019-H-1205-0001Complaint
FDA-2004-P-0008-0001HFS-832 to Nestle Prepared Foods Company
FDA-2016-V-2786-0002Acknowledgement Letter from FDA DDM to LB Entertainment
FDA-2024-S-0024-05242024-001339 - Reliance Vitamin Co. - MagnaCALM† Lemon Squeeze- PROMOTES CALM
FDA-2014-H-1499-0001Complaint
FDA-2011-S-0932-1099NBTY, Inc. (CVS Zinc 50 mg. Supplements)
FDA-2024-D-4169-0001Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and…
FDA-2015-S-0024-1712America's Finest, Inc. - Resvenox® Herbal Dietary Supplement - Antioxidant and for healthy…
FDA-2012-E-0149-0004FDA\CDER to U.S. Patent and Trademark Office - Letter
FDA-2005-P-0433-0001Citizens Petition from Allentown Health Bureau
FDA-2017-M-6525-0001Premarket Approval Response from FDA CDRH to OrthogenRx, Inc. TriVisc
FDA-1997-S-0006-0913HFS-810 to Shanti Herbs - Letter - Let 591
FDA-2009-E-0072-0005Letter from FDA/CDER to the U.S. Patent and Trademark Office - Letter
FDA-2004-H-0391-0033FDA/CDRH/OGC
FDA-2010-S-0664-0042Nexgen Pharma, Inc. - Alpha Lipoic Acid 300 mg - Antioxidant Support
FDA-2024-P-4775-0004Attachment 2 - Previous suitability petition letter 2023-P-4295
FDA-2017-D-5767-0002ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed…
FDA-2020-V-1810-0002Acknowledgment Letter from FDA DMS to James Pruitt
FDA-1999-N-0134-0114FDA
FDA-2015-N-3044-0001Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid
FDA-2015-S-0024-0282Perrigo Company of South Carolina - Multiple Claims - 4
FDA-2023-H-0569-0001Complaint
FDA-2023-H-2589-0001Complaint
FDA-2014-N-0053-1291Reference 05 - FDA Memorandum Designation of the Food Traceability List Using the…
FDA-2015-D-1839-0005FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition…
FDA-2010-D-0283-0002Draft Guidance for Industry: Chemistry, Manufacturing, and Controls Postapproval…
FDA-2025-P-0701-0009Reference 6 - NIDA.NIH
FDA-2016-R-3926-0001Complaint from FDA CTP to Manson, LLC d/b/a Sunoco
FDA-2006-P-0207-0022Report from USDA-AMS to FDA
FDA-2013-V-0606-0001DJ PROFFITT - Application for Variance
FDA-2014-N-1051-0485484 7694105 RDC CRF Subject R4044_Redacted
FDA-2012-N-0197-0018Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-1997-S-0039-2272Perrigo Company of South Carolina - Kroger® - Complete Senior - B Vitamins to Help Convert…
FDA-2014-N-0189-5481Request for Extension from Anonymous
FDA-1999-N-0134-0051Risk Assessment
FDA-2011-F-0765-0002Keller and Heckman LLP re Enviromental Assessment for Acacia Gum/FAP 1A4784
FDA-2024-H-3975-0001Complaint
FDA-2014-N-0189-6246Request for Extension from Anonymous
FDA-2016-P-2863-0068Attachment 65 - Microbiota benefits after inulin and partially hydrolized guar gum…
FDA-2017-H-3425-0001CMP Complaint Issued to Lucky’s Mini Mart, LLC d/b/a BJ’s Lincoln Rock / Shell
FDA-2020-E-2255-0008Letter from FDA CDER TO U.S. Patent and Trademark Office
FDA-2012-N-0002-0036Freedom of Information Summary ANADA 200-466 SPARMECTIN Plus Clorsulon
FDA-2017-H-3038-0001CMP Complaint Issued to Rafael E. Montilla d/b/a Garrison Deli Grocery
FDA-2019-H-3212-0001Complaint
FDA-2019-N-4248-00032nd Memorandum For Record filed by the FDA-Verification of Mailing-Cadden
FDA-2025-H-1922-0001Complaint
FDA-2014-N-0189-42345Request for Extension from Matt Waggoner
FDA-2016-H-0941-0001CTP CMP Case re Walgreen Eastern Co. Inc. d/b/a Walgreens 11619
FDA-2010-S-0664-2600Perrigo - Exchange Select Century Mature - Prostate and Colon Health
FDA-2019-V-2673-0003Letter from FDA CDRH to BULLDOG LIGHTING AND EVENTS
FDA-2009-N-0277-0003Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
FDA-2012-N-0306-0004Agency Information Collection Activities; Proposed Collection; Comment Request…
FDA-1975-P-0011-0002Asbestos Particles in Food and Drugs Notice of Proposed Rule Making; Correction
FDA-2024-H-2037-0001Complaint
FDA-2017-N-7022-0002Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket…
FDA-2014-D-0329-0005Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the…
FDA-2013-V-0075-0006Variance Application Renewal from X-Laser LLC
FDA-2017-N-6189-0091Reference 99_Wu_2002_Determination of Nicotine and Other Minor Alkaloids in International…
FDA-2025-P-5535-0001Citizen Petition from Hyman, Phelps & McNamara, P.C.
FDA-2020-N-2029-0190DP 6 2006-08-29 xPC Dehn
FDA-2023-N-3902-1022Comment from Kim Strathearn
FDA-1982-P-0018-0387Acknowledgement Letter from FDA Dockets Management Branch to Edward R. Hutchinson
FDA-2021-V-0184-0002Acknowledgment Letter from FDA DMS to Darrius Jones
FDA-2025-S-0024-00082025-000004 - PRZ NOW LLC - PROZIS ZMAN 90 Capsules- Supports recovery, strength & immune…
FDA-2024-H-5517-0001Complaint
FDA-2025-H-7393-0001Complaint
FDA-2025-P-5582-0002Acknowledgement Letter from FDA DMB to AdventaPhanna DWC-LLC
FDA-2024-H-1858-0001Complaint
FDA-2014-P-0637-0001Citizen Petition From Lachman Consultant Services, Inc.
FDA-2012-E-0161-0006Letter to U. S. Patent and Trademark Office
FDA-2018-P-3284-0023Petition for Reconsideration from Hogan Lovells US LLP
FDA-2024-V-2081-0001Variance Application from Stacy Moon
FDA-2017-N-1957-0002Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public…
FDA-2013-N-1524-2180Nomination Letter Sodium Acetate USP Trihydrate re: Comment from Fagron
FDA-2024-S-0024-00112024-000121 - Nestle Health Science - Kirkland Signature, CoQ10 300 mg- Maintain Heart…
FDA-2006-P-0208-0004Rutgers, State University of New Jersey - Supplement (2)
FDA-2006-E-0061-0011FDA/CDER to the USPTO - Letter
FDA-2024-E-0168-0005Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-1995-F-0130-0004Attachment 1 Finding of No Significant Impact re: Indirect Food Additives: Polymers
FDA-2013-V-1559-0001Coast Digital Solutions, Inc. - Application for Variance
FDA-2024-V-2218-0001Variance Application from Samantha Pezzella
FDA-2010-S-0664-0471Perrigo - Good Neighbor Pharmacy C - Protect Body Tissue from Oxidative Stress
FDA-2003-N-0313-0013Reference 2 "'Summary 1997 Economic Census, Retail Trade," U.S. Dept of Commerce…
FDA-2023-P-5234-0001Citizen Petition from Bill Drake
FDA-2018-P-1949-0045Petition Response Letter from FDA CDER to Avadel Specialty Pharmaceuticals, LLC
FDA-2004-V-0361-0001HFA-305 to Full House Productions
FDA-2009-S-0607-1221Futurebiotics, LLC. - Vitamin D3 - Supports Bone, Colon, Muscle, Immune and Breast Health
FDA-2022-H-1442-0001Complaint
FDA-2025-P-2547-0009Completeness Assessment Correspondence
FDA-2012-S-1144-2658Perrigo - Western Family® - Glucosamine Chondroitin Complex - Supports Joint Comfort
FDA-2018-H-2437-0001Complaint
FDA-2022-D-0142-0002Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional…
FDA-2010-N-0411-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guide to…
FDA-2023-S-0023-0016NDI 1273 - POLY-Y-GLUTAMIC ACID POTASSIUM SALT PGA-K - Original NDI Notification
FDA-2025-P-1373-0009Response Letter from FDA CDER to Senores Pharmaceuticals, Inc.
FDA-1995-P-0278-0002Acknowledgement Letter from FDA DMB to Hercon Laboratories Corporation
FDA-2025-P-0048-0006Attachment 4 draft labeling for the proposed product
FDA-1997-G-0376-0007Legacy Docket Log 1997G-0063
FDA-2013-V-0053-0002Acknowledgement Letter to VAST Technologies Inc.
FDA-2012-V-1140-0003Patrick Larson - Approval for Variance
FDA-2020-E-1592-0007Letter from FDA CDER to U S Patent and Trademark Office
FDA-2016-P-3082-0005Exhibit 3 CITIZEN PETITION re Citizen Petition from Ropes & Gray LLP (Pfizer Inc.)
FDA-2024-E-0434-0004Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-2017-D-5974-0004Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA)
FDA-2008-N-0131-0002FDA Response Letter to Florida's Natural Growers
FDA-2025-S-0024-03242025-000405 - International Vitamin Corporation - SmartCare Wellness Men's Prostate…
FDA-1987-N-0010-0050Background Material
FDA-2011-F-0171-0019Reference 30 - "New York Times, 1920, City’s Soda Cost Millions Monthly: Tax on Soft…
FDA-1991-G-0159-0008Reference 5 FDA, CPC International Inc. Filing of Petition for Affirmation GRAS Status…
FDA-2016-H-0843-0002Complaint
FDA-2007-N-0199-0051Hixon, Dena
FDA-2023-H-0953-0001Complaint
FDA-2021-N-0309-0005Reference 1 - C - Transcript Orthopaedic and Rehabilitation Devices Panel of 12-12-13
FDA-2017-V-4585-0001Variance Application from Event Productions LLC
FDA-2018-H-1868-0001Complaint
FDA-2023-N-3902-1554Comment from Adrienne Muncy
FDA-2017-N-6928-0001Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request…
FDA-1995-N-0054-13919Background Information to NPR1
FDA-2025-P-0832-0234Interim Response
FDA-1993-G-0218-0456Reference 10 - Dexter, L., et at "Well Water Analysis Report." Canadian Harvest USA L.P…
FDA-2016-H-1531-0001Complaint
FDA-2023-P-4658-0006Completeness Assessment Correspondence
FDA-2011-S-0932-1300NBTY, Inc. - Glucosamine Chondroitin - Joint Health
FDA-1995-P-0325-0004Exhibit III Currently Approved Package Enclosure re: Citizen Petition from Abbott…
FDA-2025-V-1282-0001Variance Application from James Steinberg
FDA-2013-S-0024-0748Perrigo - Meijer™ - Men's 50+ Formula - Complete Multivitamin, Heart Health, Immune Health
FDA-2014-H-0369-0001Complaint
FDA-2008-M-0477-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2004-N-0057-0019Agenda for 4/27/2004 HHS Importation Task Force Stakeholder meeting
FDA-2007-E-0457-0023Artes Medical Inc. - Patent Term Extension Application
FDA-2010-N-0358-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Sample…
FDA-2024-H-1891-0001Complaint
FDA-2015-N-2002-2008Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs…
FDA-2018-S-0024-01722018001336- Pharmavite LLC. - Digestive Probiotics Ultra-Strength Adult Gummies- support…
FDA-2025-P-2242-0002Acknowledgement Letter from FDA DMB to Age Reversal Unity
FDA-2018-P-0998-0001Citizen Petition from Hyman Phelps & McNamara P.C.
FDA-2023-H-0276-0001Complaint
FDA-2024-S-0024-07302024-001567 - New Generation Wellness Inc. - Supports Mood Regulation, Muscle & Bone…
FDA-2009-N-0665-0068Implantation or Injectable Dosage Form New Animal Drugs; Insulin - Final Rule
FDA-2015-N-0101-0796Reference 13-35 - Product Labels in OTC Vol. 03 HCATFM Skin care products multiple…
FDA-2010-N-0364-0001Meetings: Advancing Development of Medical Products Used in Prevention, Diagnosis, and…
FDA-2016-H-0517-0002Complaint
FDA-2020-N-0437-0001Purple Book Enhancement; Establishment of a Public Docket; Request for Comments
FDA-2023-H-5441-0001Complaint
FDA-2016-S-0024-0063Vitalize - Bodybuilding.com Foundation Beta Alanine 75 Servings - Shown to boost…
FDA-1979-P-0001-0016Envelope re: Comment from Generic Pharmaceutical Industry Association
FDA-2025-V-1214-0001Variance Application from Daniel Fraser
FDA-1977-N-0356-0020Letter from K & L Gates to FDA CDER
FDA-2002-N-0233-0060List for the Minneapolis Formal Downlink on 10/28
FDA-2022-N-2390-0203Exhibit 67
FDA-2011-N-0511-0002Agency Information Collection Activities; Proposals, Submissions, andApprovals: Current…
FDA-2019-S-0024-02912019002274 - International Vitamin Corporation - Multiple Claims (6)
FDA-2020-V-1469-0003Variance Approval from FDA CDRH to Tyler Schoeppner
FDA-2024-E-5023-0003Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2016-H-1789-0001Complaint
FDA-2017-H-4874-0001CMP Complaint Issued to Krause Inc.d/b/a Krause’s Super Valu
FDA-2010-N-0002-0086Freedom of Information Summary - [ANADA-200-457]
FDA-2011-V-0639-0002Acknowledgement Letter to Best Entertainers
FDA-1995-S-0036-0102Resuscitation Outcomes Consortium (ROC), INDs 12505 & 12506 Public Disclosure Material…
FDA-2022-N-0576-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2024-V-0254-0002Acknowledgment Letter from FDA DMS to AIBOT
FDA-2009-P-0471-0006Acknowledgement Letter to Mark Antell, et al
FDA-2020-E-2119-0003Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2021-S-0024-02542021-000331 Jarrow Formulas Inc- Jarrow Formulas 7-Keto DHEA- Supports Metabolism
FDA-1991-N-0365-0350Answer from FDA DDM to Honorable Gaylord Nelson Re: Comment from T.N. Torhorst
FDA-2009-E-0047-0002USPTO to FDA/CDER - Letter
FDA-2012-S-1144-1194HongsamNara USA Inc - Ginseng Force Energy Drink Product - Support your health naturally
FDA-1976-N-0476-0221Answer Letter from FDA to Comment from Huntingdon Research Center
FDA-2016-V-4210-0001Variance Application from Laser Ninja Productions
FDA-2019-H-4105-0001Complaint
FDA-2004-P-0406-0008Acknowledgment Letter from FDA DMB to Illinois Attorney Generals Office
FDA-2010-P-0176-0024FDA/Office for Policy Response to Ethicon Endo-Surgery (EES), Inc., November 5, 2010…
FDA-2014-N-0189-8541Request for Extension from Anonymous
FDA-2022-P-1104-0004Final Response from FDA CDER to Medexus Pharma, Inc
FDA-1997-S-0006-0673HFS-456 to Nature's Life - Letter - Let 362
FDA-2010-S-0664-0379Nutronix International - SangoCaps - Support the Body's Normal Structure and Functions
FDA-2009-N-0505-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
FDA-2017-H-4829-0001CMP Complaint Issued to 348 S and M Food Corp. d/b/a 348 S and M Food Corp.
FDA-2015-S-0024-0587NBTY, Inc. - Passion Flower - Passion Flower is a tropical flower that has been…
FDA-2010-N-0118-0009Agency Information Collection Activities; Proposed Collection; Comment Request; Prior…
FDA-2015-S-0024-1330Perrigo Co - Meijer™ promotional - Garlic Helps Support Heart and Cardio vascular Health
FDA-2011-P-0590-0003Interim Response to Kim Witczak and William Vaughn - Letter
FDA-2002-N-0323-0164Reference 3 - FDA/Regulations Policy and Management Staff (RPMS) to the Division of…
FDA-2023-P-3547-0001Citizen Petition from James T. O’Reilly
FDA-2003-S-0732-0057NDI 139 - Sheep Placenta from YAT CHAU (USA) INC.
FDA-2016-H-2597-0001Complaint
FDA-2016-N-0002-0031Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158…
FDA-2011-M-0786-0003Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2022-H-0596-0001Complaint
FDA-2014-S-0024-0580Bioterra Herbs (Vision) - Letter
FDA-2025-P-6225-00046115-James M.Love( TITUS HILLIS REYNOLDS LOVE )-11-17-2025-Citizen prtition-Appendix I
FDA-2019-P-2559-0004Letter from FDA CDER to Ajanta Pharma USA Inc
FDA-2024-H-1092-0001Complaint
FDA-2017-N-1003-0015Request for Participation (ELP) from NAMSA
FDA-2024-H-3204-0001Complaint
FDA-1980-P-0073-0022Laser Fantasy Productions Inc - Request for Extension of Compliance Date
FDA-2022-E-2224-0003Letter from FDA CDER TO U.S. Patent and Trademark Office
FDA-2010-E-0036-0001U.S. Patent & Trademark Office to FDA/CDER - Letter
FDA-2006-N-0107-0018MedWrite, Inc. - Comment
FDA-1980-N-0067-0036Reference 21 re: Public Administrative File for Over-the-Counter Vaginal Contraceptive…
FDA-2019-H-0326-0001Complaint
FDA-2004-N-0252-0002FDA
FDA-2016-V-1596-0001Variance Application from Well Turn it Up Entertainment!
FDA-2010-N-0621-0420Dr. Midthun Response to Dr. Brown-Beasley, July 5, 2011 - E-Letter
FDA-2017-H-5426-0001Complaint
FDA-2019-H-1597-0001Complaint
FDA-2011-V-0532-0001Allstage Pro - Application for Variance
FDA-2011-N-0922-0546Reference 8. FRIA - Salmonella Infection in Dogs petmd re Current Good Manufacturing…
FDA-1981-N-0012-0022HFA-305 to Thompson Medical Company Inc
FDA-2010-N-0002-0011Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin
FDA-2023-P-4320-0001Suitability Petition from Lachman Consultant Services, Inc.
FDA-2023-H-0987-0001Complaint
FDA-1997-S-0039-0367[LET242] - Jarrow Formulas, Inc. - Letter
FDA-2023-S-0024-08832023-002104 - Blueroot Health - Vital Nutrients, Ultra Pure Fish Oil 675 - Sustainably…
FDA-2019-H-3137-0001Complaint
FDA-2018-D-2173-0081Reference 17 - Integration site and clonal expansion in human chronic retroviral infection…
FDA-2016-E-0534-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2017-N-6397-0010Agency Information Collection Activities; Proposed Collection; Comment Request; Food…
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FDA-2012-D-0938-0001Draft Guidance for Industry; Availability: Abbreviated New Drug Applications; Stability…
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FDA-2013-N-0001-0112Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
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FDA-2011-N-0410-0001Agency Information Collection Activities; Proposals Collection; Comment Request; Premarket…
FDA-2007-D-0369-1969PSG_060003 - Draft Guidance on Penicillin V Potassium
FDA-2024-H-1997-0001Complaint
FDA-2014-N-0189-5775Request for Extension from Anonymous
FDA-2015-S-0024-2201NBTY, Inc. - Zinc - Immune health
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FDA-2024-H-5917-0001Complaint
FDA-2022-H-2559-0001Complaint
FDA-2011-N-0824-0001Regulatory Site Visit Training Program
FDA-2018-H-2837-0001Complaint
FDA-2024-N-5471-0628Reference 626 Weinberger Nicotine withdrawal in US 2010
FDA-2010-S-0664-1452NOW Foods - Digest Platinum Vcaps - Supports Healthy Digestion
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FDA-2023-V-4134-0001Variance Application from GoHeels Productions
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FDA-2008-N-0188-0001Food Protection Plan; Outreach Activities; Opportunity for Public Comment
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FDA-2011-N-0920-2068Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls…
FDA-1998-D-0038-0007Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their…
FDA-2002-V-0520-0003Approval Letter from FDA CDRH to Metropolitan Opera Association
FDA-2016-E-1851-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2014-E-0155-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
FDA-2016-H-4368-0001Complaint
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FDA-2024-S-0024-05952024-001407 - Hoborland Health Technology Limited - Fruvita Multi Collagen Peptides Powder…
FDA-2004-N-0057-0042Transcript of the April 14, 2004 Public Meeting
FDA-2014-H-1117-0001Complaint
FDA-2003-P-0183-0001Acknowledgment Letter from FDA DMB to Anabolic Laboratories, Inc.
FDA-2006-N-0239-0002Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of…
FDA-2021-V-0148-0001Variance Application from Sancvera Events
FDA-2008-N-0280-0002Potential for a Registry of Breat Cancer Treatment Using Thermal Ablation Devices…
FDA-2018-H-3837-0001Complaint
FDA-2016-N-2880-0004Microbiology Devices; Reclassification of Cytomegalovirus Doxyribonucleic Acid…
FDA-2023-H-5427-0001Complaint
FDA-1982-N-0011-0194Background Material
FDA-2025-P-3956-0085Koc, D., Tiemeier, H., Stricker, B. H., Muetzel, R. L., Hillegers, M., & El Marroun, H…
FDA-2012-S-1144-1009ProCaps Laboratories - Vitamin B12-500 - Vitamin B12 is essential for all energy…
FDA-2017-H-5602-0001Complaint
FDA-2017-N-1848-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic…
FDA-2025-P-5933-0002Acknowledgment Letter from FDA DMB to Kaylin Bower
FDA-2019-H-4707-0001Complaint
FDA-2025-S-0024-15462025-001667 - HEALTH & HAPPINESS (H&H) Inc - SWISSE ULTRA BEAUTY L-ERGOTHIONEINE HA…
FDA-2006-P-0210-0004Sandoz, Inc. - Amendment
FDA-2013-N-1524-1930Nomination Letter Fitalite re: Comment from Fagron
FDA-1993-G-0218-0371Section VI of Reference 3 -History of Prior Use of Similar Products in Human Nutrition re…
FDA-2016-H-2586-0001Complaint
FDA-2006-P-0007-0026ViroPharma Incorporated (ViroPharma) - Supplement
FDA-2013-S-0024-0339Perrigo Company (Smart sense - Fish Oil) - Letter
FDA-2007-M-0277-0001FDA
FDA-2014-V-2190-0003Variance Approval from FDA CDRH to HERITAGE CHURCH
FDA-2007-N-0213-0005Background Material re Revisions to the Requirements Applicable to Blood, Blood…
FDA-2022-S-0024-12102022-118 - WN Pharmaceuticals-MULTIPLE (18)
FDA-2021-P-0339-0003Attachment-I Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations…
FDA-2013-S-0024-0275Perrigo Company (Smart Sense - C) - Letter
FDA-2007-N-0152-0052Solae, LLC (6) [FDA-2007-N-0152-0048.1] - Appendix 10: Reference Articles A-C(3)…
FDA-1989-F-0156-0001Environment Assessment from Milliken & Company
FDA-2017-H-3700-0001CMP Complaint Issued to 3 Bell LLC d/b/a Buckhorn Travel Plaza
FDA-2015-S-0024-2084NBTY, Inc. - No-Flush Niacin - Cardiovascular support
FDA-2017-H-0447-0001Complaint from FDA CTP to Donut Inc. LLC d/b/a Donut Crazy
FDA-2016-N-0124-0058Reference 26 - Mangram et al, Guideline for Prevention of Surgical Site Infection re…
FDA-2020-P-1416-0020TAB 20 re Citizen Petition from Sidley Austin, LLP. (on behalf of Cell2in, Inc.)
FDA-2024-P-4387-0003Final Response Letter from FDA CVM to Kohl Harrington
FDA-1981-N-0293-0004Division of Food Technology (FDA/CFSAN) Response to the School of Public Health…
FDA-2024-D-2604-0016Reference 13 - Pettengill JB, H Rand, SS Wang, D Kautter, A Pightling, and Y Wang. 2022…
FDA-2017-V-0792-0004Variance Approval Letter from FDA CDRH to Laser Tag Pro
FDA-2014-N-1051-0663663 7694105 Survey Subject R3005_Redacted
FDA-2018-M-2983-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
FDA-2010-N-0210-0126Attachment 3 - "Executive Summary, How Front of Pack (FOP) Labels are Understood and Used…
FDA-2019-H-2437-0001Complaint
FDA-2014-N-0189-6322Request for Extension from Anonymous
FDA-2002-N-0323-004310/28 Satellite Conference Participants
FDA-2003-N-0257-0037FDA
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FDA-2006-D-0464-0008List of Panelists at Part 15 Public Hearing - Conduct of Emergency Clinical Research…
FDA-2024-V-2508-0002Acknowledgment Letter from FDA DMS to Nelson Contracting
FDA-2003-N-0161-0002Secretary's Roundtable on Obesity/Nutrition, July 30, 2003 - Transcript
FDA-2010-D-0350-0022Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
FDA-2025-H-1197-0001Complaint
FDA-2013-S-0024-0166Source Naturals - ArcticPure® Omega-3 1125 Enteric coated Fish Oil - Provides the highest…
FDA-2015-H-0493-0001Complaint
FDA-2020-H-0250-0001Complaint
FDA-2019-H-0910-0001Complaint
FDA-2007-N-0442-0006Form Letter Sample#1 Pet Food Safety [Multiple Submitters=13] - Comment
FDA-2011-S-0933-0228NDI 710, Camal Grass Cymbopogon Schoenanthus L. from Amano Abba Herbal Preparations
FDA-2019-H-3117-0001Complaint
FDA-2021-N-0471-0015PRIA Reference 13 EPA 2012 2012 Recreational Water Quality Criteria
FDA-2012-S-1144-1962NBTY Inc - Turmeric - Supports Antioxidant and Immune Health
FDA-2023-V-1978-0002Acknowledgment Letter from FDA DMS to Zejus, LLC
FDA-2004-N-0037-0016Letter to Keller and Heckman, LLP from FDA CDER
FDA-2021-P-0852-0001Citizen Petition from Lachman Consultant Services, Inc.
FDA-2017-H-5581-0001Complaint
FDA-2025-H-6937-0001Complaint
FDA-2016-E-1282-0001Patent Extension Application from Edwards Lifesciences PVT Inc
FDA-2010-S-0664-1517Letter from Perrigo Company of South Carolina
FDA-2014-P-1269-0003Citizen Petition Partial Approval and Denial Response Letter from FDA CDER to Pfizer Inc.
FDA-2023-H-1037-0001Complaint
FDA-2023-H-4105-0001Complaint
FDA-2018-P-2838-0010Letter from FDA CFSAN to Public Citizen's Health Research Group
FDA-2016-N-0124-0180178 Reference 136 - McEvoy et al, The Effect of High Concentration Isopropanol on the…
FDA-2023-P-4331-0003Attachment 1- Orange Book Listing of Sterile Water for Irrigation USP re Suitability…
FDA-2016-N-3710-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation…
FDA-2019-P-3192-0031Acknowledgment Letter from FDA DMS to US WorldMeds, LLC
FDA-2024-V-5874-0001Variance Application from Superior Contracting
FDA-2017-H-0017-0001Complaint from FDA CTP to Rajani Fuels Inc. d/b/a St Pete Food Mart / Shell
FDA-2021-V-1308-0003Variance Approval to Dubay Designs Inc from FDA CDRH
FDA-2024-H-2439-0001Complaint
FDA-2011-P-0888-0004FDA/CDER to Foley & Lardner LLP - Letter
FDA-1978-N-1446-0025Objection from Environmental Defense Fund and Public Citizen Health Research Group
FDA-2012-S-1144-2263Country Life, L. L. C. - Target-Mins/Iron - Essential for Red Blood Cell Formation
FDA-1984-G-0007-0257Background Material: E-13 For. Lang.
FDA-2021-S-0024-14412021-001561 - Indiana Botanic Gardens Inc- BOTANIC CHOICE SAFFRON- PROMOTES HEALTHY MOOD
FDA-2021-N-0471-0394FRIA Reference 1 - FDA, Standards for the Growing, Harvesting, Packing, and Holding of…
FDA-2004-V-0168-0002HFA-305 To Sergio Gonzalez
FDA-2019-H-5435-0001Complaint
FDA-2019-H-1539-0001Complaint
FDA-2007-D-0366-0002See FDA-2007-D-0366-0003
FDA-2005-D-0140-0011001 - List of References - Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus…
FDA-1994-G-0059-0013Section 10 Attachment 1 Technical Information Sheets re: GRAS Affirmation Petition from…
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FDA-2015-H-4735-0001CTP CMP Case re Woodlawn Liquors, Inc. d/b/a Woodlawn Liquors
FDA-2016-N-3118-0327200_FDA Study Data
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FDA-2017-H-5895-0001Complaint
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FDA-2019-S-0024-05982019-2867 Nutrition Express - Lindberg Hawthorn Extract 300 mg - Supports Cardiovascular…
FDA-2014-N-0189-5655Request for Extension from Anonymous
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FDA-2017-H-2328-0001CMP Complaint Issued to 312 RT 94 LLC d/b/a Lukoil / Mini Mart
FDA-1997-S-0039-2021Perrigo Company of South Carolina - Leader®- C - Vitamin C is an antioxidant - It is…
FDA-2011-N-0920-1998Reference 27-Final Rule-FDA 2013-The Reportable Food Registry_3rd Annual Report_Sept 8…
FDA-2020-V-2308-0002Acknowledgment Letter from FDA DMS to Kendall Tschache
FDA-2016-H-0598-0002Complaint
FDA-2025-E-3944-0001Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-1999-V-0006-0001Variance Attachment A
FDA-2024-V-1305-0002Acknowledgment Letter from FDA DMS to Kasey Lusk
FDA-2018-H-1083-0001Complaint
FDA-2009-N-0505-0007Agency Information Collection Activities; Proposed Collection; Comment Request…
FDA-1979-N-0328-0082Supplement from Pennwalt Corporation (Vol. 9 of 10)
FDA-1997-S-0039-2957Perrigo - Walgreens Glucosamine Chondroitin Complex - Help with Knee Comfort
FDA-2024-H-3995-0001Complaint
FDA-1989-G-0391-0155References: Articles and Publications (Abstracts and Authors McConnochie) re: Fifth…
FDA-2022-S-0024-05312022-000534 - Sync Consulting LLC- Vegamour, Gro Ageless- Support healthy hair roots
FDA-2003-N-0103-0015BACKGROUND
FDA-1995-N-0062-0027Tab A: Copy of the Draft Regulatory Action as Submitted to the Office of Management and…
FDA-2016-S-0024-1041Perrigo Company - CVS Health™- spectravite - B-vitamins help support carbohydrate, fat and…
FDA-2020-H-1525-0001Complaint
FDA-2016-P-1212-0001Citizen Petition from Medtech Products Inc.
FDA-2009-P-0462-0004Attachment 3 - "Revised Lableling For The Piedmont Animal Health Product (RIMADYL®…
FDA-1997-S-0006-1316Courtesy Letter from CFSAN to Ariix
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FDA-2017-H-0352-0001Complaint from FDA CTP to Emamaya Business, Inc. d/b/a Valero
FDA-2013-S-0024-0043NBTY Inc (Cranberry Fruit) Letter
FDA-2014-N-0189-5900Request for Extension from Anonymous
FDA-1976-N-0523-0042Background Material
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FDA-1993-G-0218-0310Reference 438/Part D-14 - Sunlight-Induced Photochemistry of Humic Substances In Natural…
FDA-2019-E-5663-0002Patent Term Extension Application from Array BioPharma Inc
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FDA-2006-P-0328-0002Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.
FDA-1990-N-0007-0032The University of Utah Reference 72 - Background Material
FDA-1980-N-0038-0616EXHIBITS C-13.3, C-13.4, C-13.5, C-13.6, C-13.7, C-15.1, C-15.2 & C-15.3
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FDA-2017-H-2670-0001CMP Complaint Issued to Vani Stores, Inc. d/b/a Vani Arco
FDA-2023-P-4283-0009Final Response Letter from FDA CDER to Pharmobedient Consulting, LLC
FDA-1981-N-0013-0006FDA
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FDA-2007-D-0070-0001FDA
FDA-2011-N-0405-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals…
FDA-2010-N-0597-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Index of…
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FDA-2011-N-0921-18696Reference 137_Suslow_2001_Water Disfection A Practical Approach_Report re Standards for…
FDA-2016-H-3522-0001Complaint
FDA-2013-V-1460-0003Variance Approval from FDA CDRH to ARK ENERGY PRODUCTIONS
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FDA-2023-N-3902-0238Attachment F Judge Rotenberg Education Center Pre Service Training Manual Comment from the…
FDA-2013-N-1317-0252Reference 17-8 RTI International Relabeling Model 2011 re Final Determination Regarding…
FDA-2018-H-2762-0001Complaint
FDA-2001-S-0575-0012NDI 89 - Isoquercetin (quercetin-3-glocoside) - SUPPORTING & RELATED MATERIALS
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FDA-2022-H-1232-0001Complaint
FDA-2022-N-0002-0024FOI Summary oA 200-724 approved July 19, 2022
FDA-2015-S-0024-0169NBTY Inc - Soothing Digestive Blend supplements - Helps with stomach discomfort
FDA-2015-P-2830-0011Attachment 15: FDA CDER NDA 20810 Clinical Pharmacology and Biopharmaceutics Review(s) re…
FDA-2000-P-0102-0042Pharmavite LLC (Kleinfeld, Kaplan and Becker, LLP) - Petition for Stay of Action
FDA-2011-E-0683-0005Determination of Regulatory Review Period for Purposes of Patent Extension; YERVOY
FDA-2019-N-3065-0227PRIA Reference 4 - Designing effective warnings, 2006 re Tobacco Products; Required…
FDA-1999-D-0048-0008Guidance for Industry Impurities in New Veterinary Medicinal Products VICH GL11 Final…
FDA-2015-S-0024-0501Pure Encapsulations, Inc. - Adenosyl/Hydroxy-B12 - Offers vitamin B12 blend for nerve and…
FDA-2016-H-3952-0001Complaint
FDA-2024-S-0024-07252024-001562 - Zebora Biotech Corp - GUT HEALTH
FDA-2009-V-0155-0001Laser Techniques Co. (LTC), LLC - Application for Variance
FDA-2015-N-0101-1060Reference 152 - BKC RED EPA 06 re Safety and Effectiveness of Health Care Antiseptics…
FDA-2024-N-5471-0477Reference 475 - Cullen Seven year patterns in US cigar 2011
FDA-2014-N-0189-5788Request for Extension from Anonymous
FDA-2018-H-4165-0001Complaint
FDA-1989-P-0168-0005Michael Foods Inc., (Crystal Foods, Inc.) - Request for Extension of Compliance Date
FDA-1999-N-2447-0001Physician Labeling and Patient Labeling for Progestational Drug Products; Warnings and…
FDA-1982-P-0018-0049Background Material
FDA-2017-H-2137-0001CMP Complaint Issued to Balaji Foodmart 12, LLC d/b/a The Food Mart
FDA-2025-E-0495-0003Exhibit A
FDA-2023-E-3237-0003Letter to U. S. Patent and Trademark Office
FDA-2023-V-2919-0001Variance Application from LaserAnimation Sollinger GmbH
FDA-2007-S-0484-0103NDI 410 - Dunaliella Dried Powder - Original NDI Notification
FDA-2010-N-0631-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance…
FDA-2021-S-0024-04742021-000696 FoodState - MegaFood Women's Multi Gummies - supports healthy memory and…
FDA-1977-N-0014-0969Answer Letter from FDA to Comment from The Honorable Eldon Rudd, United States House of…
FDA-2022-H-2248-0001Complaint
FDA-2008-N-0523-0004American Dental Association (ADA) - Council's Statement [re FDA-2008-N-0523-0003]
FDA-1977-N-0421-0006Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of…
FDA-2024-S-0024-13962024-002293 - DrVita Inc- Spring Valley Mushroom Complex 30ct- Supports heart health…
FDA-2013-V-0861-0003FDA/CDRH Response to Creative Sound & Lighting - Approval of Variance
FDA-2008-D-0530-0024Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2023-P-2985-0004Attachment B - References cited in Attachment A RE Citizen Petition from The Protein…
FDA-2019-H-5851-0001Complaint
FDA-2016-H-1356-0001Complaint
FDA-2019-H-4659-0001Complaint
FDA-1977-N-0014-1112Answer Letter from FDA/Office of Legislative Services to Honorable Hubert H. Humphrey…
FDA-2015-S-0023-0087NDI 882 - Niagen from Spherix Consulting, Inc.
FDA-2020-D-1136-0044Review Timelines for Applicant Responses to Complete Response Letters When a Facility…
FDA-2017-N-0001-0026Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal
FDA-2024-D-2274-0002Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for…
FDA-1997-S-0006-0061HFS-800 to Aska Corporation
FDA-2016-H-0092-0001CTP CMP Case re Thomas Mcallister d/b/a T. Mcallister Newsstand
FDA-2019-N-0002-0042FOI Summary oA 200-658 approved October 11 2019
FDA-1991-N-0025-0001HFS-832 to Emord & Associates, PC
FDA-1977-N-0002-1719Answer from FDA to Comment from Honorable Virginia Smith Congress of the United States
FDA-2023-N-3902-1279Comment from Joanne Lyon
FDA-1998-P-0115-0009Citizen Petition from Whitman, Breed, Abbott & Morgan LLP on behalf of Pharmaceutical…
FDA-2010-D-0370-0004Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling…
FDA-2013-V-0038-0003Brothers From Another Mother LLC - Amemdment
FDA-2014-N-0189-6409Request for Extension from Anonymous
FDA-2015-E-2604-0008Letter from U.S. Patent and Trademark Office to Gilead Sciences, Inc.
FDA-2021-N-1333-0009Reference 9-Preventing Patients From Receiving Leaking or Empty Containers of Medical Gas…
FDA-2017-D-5868-0006Requests for Reconsideration at the Division Level Under the Generic Drug User Fee…
FDA-2014-N-0053-0083PRIA Reference 10 - US Food and Drug Administration 2009 - Prevention of Salmonella…
FDA-2016-H-1475-0001Complaint
FDA-2002-D-0053-0004FDA
FDA-2015-H-3771-0001CTP CMP Case re Sarah Amir LLC d/b/a Gold Hill Shell / Adams Mart
FDA-2021-D-0563-0002Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Current Good…
FDA-1993-P-0085-0003FDA - Notice
FDA-2004-P-0009-0002Acknowledgment Letter from FDA DMB to Dr. Sidney M. Wolfe
FDA-2024-E-3577-0002Patent Extension Application from Proskauer Rose LLP (on behalf of Akebia Therapeutics…
FDA-2016-P-0135-0001Citizen Petition from Hyman, Phelps & McNamara, P.C. - Per Petitioner, withdrawal of…
FDA-2023-N-3902-1398Comment from Lindsey Anderson
FDA-2019-S-0024-04652019002366- Renew Life - RenewLife Pro-Care Flora Adult 50+ Probiotic 25B 30ct - Support…
FDA-2012-V-0655-0003FDA/CDRH Response to Harborside Productions LLC - Approval for Variance
FDA-2008-Q-0270-0006Appendix D - References Part 2 - Health Claim Notification
FDA-2015-S-0024-1689Perrigo Company of South Carolina - Multiple Claims - 2
FDA-2015-H-4360-0001CTP CMP Case re Donovan’s Reef Lounge and Package Store, Inc. d/b/a Donovan’s Reef
FDA-2014-N-0189-5867Request for Extension from Anonymous
FDA-2011-S-0932-2795Perrigo - Trunature - Promotional - Chromium is a trace mineral that plays a role in the…
FDA-2015-N-0001-0051Transcript of the March 30-31, 2015 Gastroenterology Regulatory Endpoints and the…
FDA-1997-S-0039-1969The Herbalist - Menapplause! - Supports normal glandular system function
FDA-1980-N-0049-0048Reference 16: Cowell, J. L., et al., "Separation, Purification, and Properties of the…
FDA-2024-V-2158-0003Variance Approval Letter from FDA CDRH to Ronald Register
FDA-2015-P-1722-0007Tab 8 Helsinn Exela NDA Clinical Review re: Citizen Petition from Hogan Lovells
FDA-2010-S-0664-2049Perrigo Company of South Carolina - Dolgencorp, LLC DG health-B6 - Enhances the body's…
FDA-2023-V-0029-0003Variance Approval from FDA CDRH to Laser and Sound Design
FDA-2025-H-6252-0001Complaint
FDA-2023-H-5183-0001Complaint
FDA-2018-H-1973-0001Complaint
FDA-2016-H-0948-0002Complaint
FDA-2024-P-5378-0003Attachment 1
FDA-1997-S-0039-1398Horizon Nutracueticals - Echinacea Root - is one of North America's most celebrated and…
FDA-2013-V-0265-0002Acknowledgement Letter to Roll N Mobile LLC
FDA-2023-E-3240-0001Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-2014-C-1552-0002Listing of Color Additives Exempt From Certification; Spirulina Extract
FDA-2024-H-5896-0001Complaint
FDA-2006-P-0338-0090Attachment 79 - "Letter From Dr. Kathleen Ellword to FDA/CFSAN 6/21/2007" - [Compassion…
FDA-2020-S-0024-13262020-001498 - Atrium-Innovations - Genestra Brands, D-Mulsion 1000 (Natural Berry Flavor)…
FDA-2020-E-2255-0003Letter from U.S. Patent and Trademark Office to Kilpatrick Townsend & Stockton LLP - West…
FDA-1977-N-0014-1060Answer Letter from FDA/Office of Legislative Services to Honorable Hubert H. Humphrey…
FDA-2016-S-0024-1615Perrigo Company of South Carolina - Shopko® - Hair, Skin & Nails - Antioxidants help fight…
FDA-2023-H-0210-0001Complaint
FDA-2016-N-0001-0020Nonprescription Drugs Advisory Committee; Notice of Meeting
FDA-2023-H-1769-0001Complaint
FDA-2020-S-0024-09132020-001093 LifeVantage- Protandim Nrf2 Synergizer- Supports the body’s natural ability to…
FDA-1997-S-0039-2580NUTRAGENESIS - Helps Support healthy Immune function
FDA-2025-H-5127-0001Complaint
FDA-2000-P-0152-0013Background Material
FDA-1999-N-0083-0003Joe DeGeorges [HFD-24] - Slides
FDA-1993-N-0057-0023FDA
FDA-2025-P-0440-0001Citizen Petition from Conlustro Research
FDA-1999-N-0095-0001Agency Information Collection Activities: Proposed Collection; Comment Request; Food…
FDA-2021-P-1175-0004Attachment 2 - Draft proposed package insert RE Suitability Petition from Felix…
FDA-2019-H-3322-0001Complaint
FDA-1991-N-0014-0013FDA
FDA-1977-N-0014-1097Answer Letter from FDA/Office of Legislative Services to Honorable Hubert H. Humphrey…
FDA-1997-S-0039-0410Global Healing Center Inc. (Paratrex) LET907 - Letter
FDA-2018-N-0188-0114Reference PROP - FDA_CDER_Response_to_PROP_Partial_Petition_Approval_and_Denial
FDA-1997-S-0039-2106Perrigo Company of South Carolina - Kroger® - One Daily - Supports Physical Energy and…
FDA-2019-E-5421-0007Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2012-N-0110-0005Agency Information Collection Activities; Announcement of Office of Management and Budget…
FDA-2005-P-0319-0010Exhibit 17 - "Federal Register Vol. 65, No. 47, Thursday, March 9, 2000" - [Luitpold…
FDA-2025-H-4398-0001Complaint
FDA-2012-S-1144-1356NOW Foods - Protocol for Life Balance Virility for Men - Supports Testosterone Levels…
FDA-2025-H-3563-0001Complaint
FDA-2016-H-3732-0001Complaint
FDA-2010-P-0111-0003Exhibit B - "Lialda - Mesalamine Tablet, Delayed Release, Highlights of Prescribing…
FDA-2003-N-0103-0017BACKGROUND
FDA-2021-N-0874-0083Intarcia's Appeal of EMDAC Hearing Initial Decision - Exceptions Filed Material Issues of…
FDA-2016-P-3082-0004Exhibit 2 Citizen Petition re Citizen Petition from Ropes & Gray LLP (Pfizer Inc.)
FDA-2023-H-0461-0001Complaint
FDA-2018-S-0024-05322018001641-Payless auto parts inc- Triple Max xxx- Male enhancement
FDA-1991-N-0365-0342Answer from FDA DDM to Honorable Bill Ereck Re: Comment from RA Utterbach, MD
FDA-1997-S-0006-0797HFS-810 to Premier Direct Inc. (Gronek & Armstrong) - Letter - Let 486
FDA-1976-N-0476-0069Letter from FDA to Inveresk Research International
FDA-2018-H-3352-0001Complaint
FDA-2021-V-0085-0002Acknowledgement Letter from FDA DMS to Ford Audio-Video Systems, LLC
FDA-2024-N-3948-0001Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle…
FDA-2022-H-1390-0001Complaint
FDA-2024-E-0223-0002Patent Term Extension Application from Cooley LLP (on behalf of Gamida Cell Ltd.)
FDA-2024-V-1309-0001Variance Application from Michelle Baddar
FDA-2019-H-4867-0001Complaint
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FDA-2022-H-2285-0001Complaint
FDA-2018-P-2755-0007Interim response from FDA CDER to Ascend Laboratories, LLC
FDA-2018-P-4143-0036Supplement material for Docket FDA
FDA-2024-H-5342-0001Complaint
FDA-2025-H-1936-0001Complaint
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FDA-2011-E-0268-0002Drugs @ FDA Update
FDA-2024-H-2997-0001Complaint
FDA-2016-S-0024-0588Perrigo Company - Promotional - Vitamin E is an antioxidant
FDA-2009-E-0206-0003U.S. Patent and Trademark Office to the FDA/CDER - Letter
FDA-1998-N-0575-0006Agency Information Collection Activities; Announcement of OMB Approval; Guidance for…
FDA-2016-H-2424-0001Complaint
FDA-2024-N-3356-0001Medical Devices; General Hospital and Personal Use Devices; Classification of the…
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FDA-2017-H-0221-0001Complaint from FDA CTP to Perry Red Apple Corporation d/b/a Perry Red Apple Market
FDA-2019-S-0024-09062019-002698 - Primal Nutrition, LLC- MULTIPLE CLAIMS (2)
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FDA-1997-S-0039-2587Enzymatic Therapy, Inc. - Arterial Therapy- Support for healthy arteries
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FDA-2016-H-2619-0001Complaint
FDA-2016-S-0024-0049Source Naturals - 5-HTP, a dietary supplement - Help support healthy levels of serotonin…
FDA-2018-H-3133-0001Complaint
FDA-2019-H-0384-0001Complaint
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FDA-1984-N-0259-0046Exhibit G - 3.39 re: Disclosure of Data and Information from Center for Drugs and…
FDA-2018-H-1936-0001Complaint
FDA-2023-S-0024-05802023-001258 - Arbonne International LLC - Arbonne International, MushroomPowder Daily…
FDA-2021-N-0764-0001Compliance Policy Guide Sec. 510.800 Beverages—Serving Size Labeling; Compliance Policy…
FDA-2025-H-1614-0001Complaint
FDA-2005-P-0063-0015Tab 11 - Section IX - Regulatory Control of Risk[FDA-2005-P-0063-0005]
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FDA-1997-S-0006-0952HFS-810 to Enzymatic Therapy Inc. - Letter - Let 623
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FDA-1993-E-0058-0002Determination of Regulatory Review Period for Purposes of Patent Extension; PAXIL
FDA-2021-P-0513-0004Attachment 2 - COLESTID PI FLAVORED COLESTID- colestipol hydrochloride granule, for…
FDA-2016-P-3509-0002Acknowledgement Letter from FDA DDM to Metabolic Therapy Inc
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FDA-2018-V-3534-0001Variance Application from Mark Bernheimer
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FDA-1983-N-0138-0022Proposed Rule: Extension of Comment Period
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FDA-2003-E-0114-0007U.S. Patent and Trademark Office
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FDA-2019-H-2579-0001Complaint
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FDA-2016-H-1950-0001Complaint
FDA-2019-N-3065-0613Reference 18 - Tobacco Product Use Among Adults, 2018
FDA-1997-S-0039-1692Life Force International - Intestinal Tone - It also helps improve the absorption of…
FDA-1977-P-0289-0002Reclassification Petition for the O.H.C Ventilator - Memorandum
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FDA-2023-H-4218-0001Complaint
FDA-2006-S-0544-0032NDI 313 - Extract of Garcinia Cambogia, (-) -Hydroxycitric acid - SUPPORTING & RELATED…
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FDA-2023-H-2495-0001Complaint
FDA-2017-H-3681-0001CMP Complaint Issued to Sabor Nica Restaurant Corporation d/b/a Sabor Nica Restaurant
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FDA-2009-V-0504-0001Coherent Inc. - Application for Variance
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FDA-1997-N-0019-0010Duramed Pharm, Inc/Barr Labs., Inc
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FDA-2016-N-2066-0007Agency Information Collection Activities; Proposals, Submissions, and Approvals
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FDA-2011-D-0649-0003Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special…
FDA-2013-N-1428-0016Agency Information Collection Activities; Submission for Office of Management and Budget…
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FDA-2013-D-0589-0002Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing…
FDA-1997-S-0006-1871Courtesy letter and related material from CFSAN to AceBiome
FDA-1975-N-0012-0780Lonza FINAL July 3_2019 Prelim Meeting Preliminary Comment for July 2019 MTG (002)
FDA-2015-N-0540-0475Presentation from the American Institute of Homeopathy
FDA-2016-H-1479-0001Complaint
FDA-2010-S-0664-1798Purevive Health Sciences, LLC - TigerMax PF-TM04 - Overall Positive Effect on Sexual…
FDA-2021-V-0466-0002Acknowledgment Letter from FDA DMS to Koma Productionz
FDA-2024-P-4956-0008Completeness Assessment Correspondence
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FDA-2012-S-1144-2065Pur Pak, L. L. C. - Pur Pak - Supports Active Lifestyles
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FDA-2016-N-2527-0001Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco…
FDA-2022-P-0451-0002Acknowledgment Letter from FDA DMS to Chelsea Kent
FDA-2018-H-0373-0001Complaint
FDA-2025-P-1373-0005Attachment 3 - Draft labeling for the proposed products
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FDA-2025-V-0969-0001Variance Application from Kreative AV Inc.
FDA-2014-P-0724-0006Exhibit 4 Conformer Classification Citizen Petition From Barbara Spohn-Lillo
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FDA-2008-P-0329-0016FDA/CDER to Osmotica Pharmaceutical Corp. - Response to Citizen Petition
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FDA-2010-S-0665-0113NDI 649, Pine Tree Phytosterols from Arboris, LLC
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FDA-2018-V-0248-0002Acknowledgement Letter from FDA DDM to The Ocotillo Group Productions
FDA-2008-P-0366-0004Sidley Austin LLP to the Division of Dockets Management - Letter
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FDA-1992-P-0389-0002Acknowledgement Letter to Covington & Burling (McNeil Specialty Products Co.)
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FDA-2024-P-5165-0008Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.
FDA-2024-H-5031-0001Complaint
FDA-2019-P-4979-0003Attachment-1 Approved Drug Products with Therapeutic Equivalence Evaluations (Electronic…
FDA-2009-P-0218-0001PharmaForce - Citizen Petition
FDA-1999-N-0113-0059Background Information
FDA-2025-H-0052-0001Complaint
FDA-2019-V-3808-0001Variance Application from Clay Paky S. p. A.
FDA-2005-M-0181-0001FDA
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FDA-2019-H-5316-0001Complaint
FDA-2015-V-0881-0001Variance Application from KNIGHTS MUSIC
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FDA-2016-H-0892-0001CTP CMP Case re Neekee LLC d/b/a Blue Fish Liquor and Cigars
FDA-2014-V-1096-0003Letter from Audio Visual Imagineering re Variance Application from South Carolina State…
FDA-2009-P-0425-0003Enclosure - Elbek, G., "Soy Endocrine Disruptors and Soy Antinutrients Cause Irreversible…
FDA-1989-G-0401-0004Introduction and Summary
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FDA-2007-N-0198-0006FDA/CFSAN/ONLDS
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FDA-1993-G-0218-0159Section 2/Subsection B of Reference C-8 - Figure: Baked Moisture Content of Cakes…
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FDA-1997-S-0006-1137New Century Company LET1137 Response From FDA/CFSAN - Courtesy Letter
FDA-1977-N-0016-0016Memorandum of Background Materials Concerning the Notice of Intent for Ionizing Radiation…
FDA-2000-N-0190-0032Reference 16 - "U.S. Department of Health and Human Services. Healthy People 2010…
FDA-2020-V-1781-0003Letter from FDA CDRH to Redeeming Light Ministries Inc.
FDA-2010-E-0661-0001Aventis Pharma S.A. - Patent Term Extension Application
FDA-1977-N-0014-0967Answer Letter from FDA to Comment from The Honorable Gillis Long, United States House of…
FDA-2025-H-7109-0001Complaint
FDA-2016-H-2109-0001Complaint
FDA-2016-H-4492-0001Complaint
FDA-2023-E-1948-0003Letter from U.S. Patent and Trademark Office to Lathorp GPM, LLP
FDA-2020-E-1282-0004Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2014-N-1051-0149147 7694105 Diary Subject R3020_Redacted
FDA-2014-D-0055-0409Quantitative Sodium Goal Assignment Table_1_App 1_FINAL
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FDA-2016-N-1111-1643Attachment 3b. Data on patients sucessfully transitioned from ESD therapy re: Comment from…
FDA-2016-V-3734-0003Approval letter from FDA CDRH to Austin Amsler
FDA-2007-P-0243-0001Acknowledgement Letter to Michael J. Dochniak
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FDA-1989-P-0008-0033Background Material
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FDA-2018-N-3522-0001Use of the Names of Dairy Foods in the Labeling of Plant-Based Products
FDA-2024-H-0389-0001Complaint
FDA-2019-V-0483-0002Acknowledgement Letter from FDA DDM to Lighting Technologies International LLC
FDA-1993-N-0448-0002M1 - Memo from HFZ-312 to Jerome E Dennis
FDA-1997-S-0006-1547Courtesy letter and related material from CFSAN to CATALO Naturals Limited
FDA-2025-H-6716-0001Complaint
FDA-2005-N-0106-0001Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance…
FDA-2021-M-0820-0002Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications
FDA-2018-H-1273-0001Complaint
FDA-2016-N-4232-0001Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop…
FDA-2017-H-0305-0001Complaint from FDA CTP to Family Dollar Stores of Florida, LLC d/b/a Family Dollar Store…
FDA-2018-V-1289-0001Variance Application from Mount Ararat Church
FDA-2006-P-0007-0024ViroPharma Incorporated (ViroPharma) - Supplement
FDA-1993-G-0221-0021Appendix J Chronic Toxicity Study re: Tara Gum GRAS Affirmation Petition
FDA-2010-S-0665-0163Reference 4- Amendment New Dietary Ingredient re NDI 658, Calcium Formate from Burdock…
FDA-2014-S-0023-0095NDI 849 Amorphophallus konjac extract - Substantive Amended NDI Notification
FDA-2010-S-0664-1516PepPod - PepPod Power Powder - Helps improve energy, mental concentration, immunity and…
FDA-2013-V-1342-0001LyonLabs, LLC - Application for Variance
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FDA-2025-E-0371-0004Letter from U.S. Patent and Trademark Office to FDA CDER
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FDA-1978-N-0027-0068Tab H.8: Memorandum of Telephone Conversation Re: Skin Protectant Drug Products for Over…
FDA-2018-H-4451-0001Complaint
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FDA-2015-E-4704-0001Patent Extension Application from Marshall, Gerstein & Borun, LLP ( on behalf of…
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FDA-2015-D-4021-0028Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data; Guidance for…
FDA-2019-H-3743-0001Complaint
FDA-2024-H-4480-0001Complaint
FDA-1995-S-0036-0068Northfield Laboratories Inc BB IND 10719
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FDA-2013-D-0749-0002Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and…
FDA-2019-H-3060-0001Complaint
FDA-2014-N-0189-7294Request for Extension from Anonymous
FDA-2017-H-4502-0001CMP Complaint Issued to B.T. Rand Oil Company d/b/a Rand Oil Co / Citgo Fast Break (CMS)
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FDA-2025-H-4188-0001Complaint
FDA-2014-S-0024-0912Natural Factors Nutritional Products LTD (Acetyl-L-Carnitine) - Letter
FDA-2013-P-0337-0001Hyman, Phelps & McNamara, PC - Petition for Stay of Action
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FDA-2012-N-0294-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food…
FDA-2011-N-0400-0386Supplement from the American Frozen Food Institute
FDA-2018-H-2957-0001Complaint
FDA-2015-V-1603-0001Variance Application From Fog Man Enterprises LLC
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FDA-1975-N-0014-0004Animal Food or Feed; Prohibited Substances; Extension of Time for Comments (NEC1)
FDA-2024-V-1299-0003Variance Approval Letter from FDA CDRH to Aayush Patel
FDA-1997-S-0039-2567Perrigo Company of South Carolina - Meijer - Glucosamine Chondroitin - Antioxidant…
FDA-2014-N-2244-0115Reference 107 FAO-WHO_2010_CODEX Alimentarius Code of Hygienic Practice for Fresh Fruits…
FDA-2019-H-1692-0001Complaint
FDA-2003-D-0152-0005FDA
FDA-2024-S-0024-03432024-001065 - Fresh Hemp Foods Ltd. - Manitoba Harvest, Organic Bioactive Fiber Chocolate…
FDA-2014-S-0024-0752Perrigo Company (H E B - Complete) - Letter
FDA-2012-E-0196-0013Acknowledgement Letter to Sterne, Kessler, Goldstein & Fox P.L.L.C.
FDA-2003-N-0102-0010HF-1
FDA-2023-H-0621-0001Complaint
FDA-2025-E-0360-0001Letter from U.S. Patent and Trademark Office to FDA CDER
FDA-2016-N-3118-0153redacted_099_Memo Pharmacovigilance Activity
FDA-2022-P-2998-0003Supplement from Nexus Pharmaceuticals
FDA-2024-H-3593-0001Complaint
FDA-2017-D-6702-0005Request for Extension from Advanced Medical Technology Association (AdvaMed)
FDA-2017-N-0067-0001Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic…
FDA-2024-D-1829-0003Request for Extension from Biotechnology Innovation Organization (BIO)
FDA-2019-H-2616-0001Complaint
FDA-2018-S-0024-04432018001567- International Vitamin Corporation- MULTIPLE CLAIMS (3)
FDA-2015-V-2750-0001Variance Application from Jeffrey Cobb
FDA-2015-S-0024-1858NBTY lnc. - Vitamin B 12 Gummies Supplements - Energy Support
FDA-1977-N-0002-1060Answer Letter from FDA/Office of Legislative Services to Honorable Richard S. Schweiker…
FDA-2015-S-0024-3598Brodicol Products DBA Creekside Natural Therapeuitics - Academic Edge Jr. - Focus and…
FDA-2013-N-0001-0113Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
FDA-2011-S-0932-2903NBTY, Inc. - Equaline Chewable Vitamin C Mixed Berry Flavor Supplements - Supports Immune…
FDA-1978-N-0018-0080Letter from FDA CDER to C. O. L. I. P. A.
FDA-2019-E-1174-0006Determination of Regulatory Review Period for Purposes of Patent Extension; SEGLUROMET
FDA-2006-E-0318-0004USPTO to FDA/CDER - Letter
FDA-2014-H-1967-0001Complaint
FDA-2017-H-0042-0001Complaint from FDA CTP to Family Dollar Stores of Missouri, LLC d/b/a Family Dollar 7091
FDA-1998-V-0020-0001Variance Approval Letter from FDA CDRH to Wild Adventures Valdosta, LLC
FDA-2007-D-0369-2278PSG_022315 - Draft Guidance on Dexamethasone
FDA-2004-N-0315-0001FDA
FDA-1982-G-0253-0007Letter from FDA CFSAN to Devro, Inc.
FDA-2010-S-0664-0297Anabolic Labs, LLC - Niacin Hex - Niacin Hex No Flush - Cholesterol Support
FDA-2007-P-0168-0017CareToLive - Supplement to Citizen Petition
FDA-2017-P-6809-0003Interim Response Letter from FDA CDER to Freyr Inc
FDA-2003-Q-0292-0001Acknowledgement to Emord & Associates, PC (07/07/03)
FDA-2015-P-1449-0003Acknowledgement Letter from FDA DDM to REGCON Solutions LLC
FDA-2023-V-4000-0003Variance Approval from FDA CDRH to Immersiv Colorado
FDA-2025-S-0024-05472025-000633 - Vahdam Teas Pvt. Ltd. - Vahdam India Turmeric Ashwagandha - Stress support
FDA-2011-V-0202-0002Acknowledgement Letter to Leightronix, Inc.
FDA-2006-P-0451-0001See FDA-2006-P-0451-0002
FDA-2018-P-1869-0007Non availability of samples statement from pharmacy re: Citizen Petition from Aurobindo…
FDA-2001-P-0194-0002FDA
FDA-2016-P-2342-0003Draft Guidance on Metaxalone re Citizen Petition from Sovereign Pharmaceuticals, LLC
FDA-2018-P-3327-0004Attachment 2 re Citizen Petition from Hyman, Phelps & McNamara, PC
FDA-1997-S-0006-0798HFS-810 to NOW Foods - Letter - Let 487
FDA-2025-S-0024-14312025-001550 - Blueroot Health - Fairhaven Health, Postnatal Multivitamin Essentials with…
FDA-2022-N-3012-0001Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35…
FDA-2013-P-1079-0011Kalb et al_IU Final Rule_Response_3-26-18
FDA-2024-H-3427-0001Complaint
FDA-1977-N-0025-0189Appendix II re: Comment from Wyeth Consumer Healthcare
FDA-2013-P-1612-0443Citizen Petition Denial Letter to Lee Wilson
FDA-2024-H-0571-0001Complaint
FDA-2009-D-0508-0002Registration and Product Listing for Owners and Operators of Domestic Tobacco Product…
FDA-2018-H-3866-0001Complaint
FDA-2023-V-4850-0002Acknowledgment Letter from FDA DMS to David Buchanan
FDA-2015-P-2820-0074Amendment (third) from Center for Responsible Science (CRS)
FDA-2024-P-1030-0004Exhibit 2 - FOIA Response from FDA CTP
FDA-2025-H-3923-0001Complaint
FDA-2019-V-5036-0002Acknowledgment Letter from DMS to Show Imaging, Inc
FDA-2011-P-0093-0001Larken Laboratories, Inc. (Sovereign Pharmaceuticals, LLC) - Citizen Petition
FDA-2012-S-1144-2510Perrigo Company of South Carolina - Equate-One Daily - Supports Memory & Concentration
FDA-1991-N-0430-0001Antibiotics in Combination with Analegsic Substances, Antihistamines and caffeine; Notice…
FDA-2023-H-5467-0001Complaint
FDA-2017-H-5540-0001Complaint
FDA-2015-P-0065-0027Citizen Petition Denial Response Letter from FDA CDER to Allergan, Inc. and Physical…
FDA-2004-N-0258-0166Reference 31 - Rationale Used to Amend RACCs re Food Labeling: Serving Sizes of Foods that…
FDA-1999-D-0081-0051Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent…
FDA-2024-D-1243-0002Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products…
FDA-2016-S-0024-0090Doctor's Best Inc - Calm with Zembrin (DRB-0456) - Helps combat stress and tension
FDA-2016-H-0575-0002Complaint
FDA-2016-H-0380-0001CTP CMP Case re Capitol Petroleum LLC d/b/a Capitol Westgate Mobil
FDA-2024-D-3863-0114Reference 111 - Rieder, H.L., et al., Extrapulmonary tuberculosis in the United States. Am…
FDA-2022-E-0937-0008Letter from FDA CDER to U.S. Patent and Trademark Office
FDA-2017-H-4386-0001CMP Complaint Issued to Paul and Jean Leopold d/b/a P and J’s Mini Mart / Shell
FDA-1993-F-0046-0004Secondary Direct Food Additives Permitted in Food for Human Consumption; Correction
FDA-2019-M-5741-0001Premarket Approval for P170019 S006 - Foundation Medicine, Inc FoundationOne® CDx
FDA-2022-V-1051-0003Variance Approval Letter from FDA CDRH to Scomarc INC DBA MB Lounge
FDA-1980-N-0038-0181Ciba-Geigy Corp.; lodochlorhydroxyquin and Hydrocortisone; Notice of Hearing
FDA-2014-N-0001-0070Meetings: Revamping Microbiological Test Methods for Contact Lenses Products; Workshop
FDA-2024-S-0024-05522024-001384 - Marco Pharma International LLC - MARCO PHARMA, VISCUM- support…
FDA-2021-N-1333-0030Reference 5--Postmarketing Safety Reporting Draft Guidance
FDA-2023-H-1541-0001Complaint
FDA-2016-V-1173-0003Variance Approval from FDA CDRH to PARTY PATROL ENTERTAINMENT
FDA-2009-P-0103-0003FDA/CDER Response to Hoffmann-LaRoche Inc., and Roche Palo Alto LLC - Petition Denial
FDA-2016-S-0024-0799MitoQ Ltd. - MitoQ® Heart - SUPPORTS: HEART AND CIRCULATORY HEALTH, BLOOD PRESSURE AND…
FDA-2020-S-0024-0972SFC2020-001157 i-Health Inc - Culturelle Immune Defense Packets - Supports digestive…
FDA-2020-E-1264-0003Letter from U S Patent and Trademark Office
FDA-2020-E-1273-0004Letter to U S Patent and Trademark Office
FDA-2019-H-4112-0001Complaint
FDA-1978-N-0011-0003Antiperspirant Drug Products for Over-The-Counter Human Use Establishment of A Monograph…
FDA-2024-S-0024-01332024-000625 - Viva Naturals Inc. - Viva Naturals Inc., Triple-Strength Omega-3 Fish Oil…
FDA-1997-S-0006-0201FDA/CFSAN to Pure Research Products LLC
FDA-1977-N-0002-1699Answer from FDA to Comment from the Honorable Joseph Early Congress of the United…
FDA-1990-G-0246-0246Appendix 7B - Monographs and Supplements: Sucrose: Food Chemicals Codex, 3rd ed., suppl. 3…
FDA-2023-H-5310-0001Complaint
FDA-2013-N-1485-0001Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use…
FDA-1999-F-0021-0001Notice of Filing of Food Additive Petition (FAP 9M4673), Caudill Seed Co., Inc.
FDA-2009-S-0607-0661Hansai, Inc. and Umeken USA, Inc. - Diet Meta Plum - Weight Maintenance Supplement
FDA-2025-H-7431-0001Complaint
FDA-2014-E-2331-0001Letter from U.S. Patent and Trademark Office
FDA-2015-N-1765-0060Reference 58 - Economic Impact Analyses of FDA Regulations
FDA-2017-H-1759-0001CMP Complaint Issued to Kroger Limited Partnership I d/b/a Kroger Fuel Center J-427
FDA-2017-H-5851-0001Complaint
FDA-2015-H-4216-0001CTP CMP Case re Ralph’s Supermarket, LLC d/b/a Ralph’s Supermarket
FDA-2017-E-6741-0001Patent Extension Application from Wilmer Hale LLP (on behalf of Melinta Therapeutics…
FDA-2005-H-0506-0017GCF-1, TMJ Implants, Inc. and Robert W. Christensen and Maureen K . Mooney
FDA-2025-S-0024-01842025-000261 - Laird Superfood Inc - Laird Superfood Focus and Memory Mushrooms - Supports…
FDA-2021-N-0212-0001Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of 19 New Drug Applications
FDA-2013-N-1043-0018Reference 7-Chung and Goepfert 1970 Growth of Salmonella re Qualitative Risk Assessment of…
FDA-2017-P-6208-0005Withdrawal of Citizen petition for INC Research/inVentiv Health

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