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Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health EmergencyFDANonrulemaking
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In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs; AvailabilityFDANonrulemaking
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Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Food and Drug Administration’s Foods Program Guidance AgendaFDANonrulemaking
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Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestFDANonrulemaking
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Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; AvailabilityFDANonrulemaking
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Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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Patent Term Extension Application for BYLVAY (odevixibat), Patent No. 10,011,633FDANonrulemaking
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Patent Term Extension Application for BYLVAY (odevixibat), Patent No. 10,093,697FDANonrulemaking
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Patent Term Extension Application for BYLVAY (odevixibat), Patent No. 9,694,018FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. Patent No. 8,143,240FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. Patent No. 8,785,427FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. Patent No. 8,865,690FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. Patent No. 9,211,295FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. Patent No. 9,433,628FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone), U.S. 9,486,458FDANonrulemaking
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Patent Term Extension Application for WINLEVI® (clascoterone) US Patent No.10,159,682FDANonrulemaking
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Patent Term Extension Application for PEPAXTO (melphalan flufenamide), Patent No. 6,992,207FDANonrulemaking
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Cargill, Incorporated; Filing of Food Additive PetitionFDARulemaking
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DAB Civil Money Penalty; Kim's Convenience Stores, Inc. d/b/a Kim's / Shell; CLOSED 3/11/2026FDANonrulemaking
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NADA/ANADA NoticesFDARulemaking
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Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; AvailabilityFDANonrulemaking
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Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; RenewalFDANonrulemaking
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General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for MelanomaFDANonrulemaking
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Accelerating Access to Critical Therapies for ALS Act – ACT for ALS - Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS), Docket for Public CommentFDANonrulemaking
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Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a HearingFDANonrulemaking
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Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement.FDANonrulemaking
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Opportunity for Feedback on Development and Dissemination of Educational Materials on Rare Disease Drug DevelopmentFDANonrulemaking
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Requests that the FDA comply with FOIA law and post publicly on the FDA FOIA reading room all documents requested through various FOIA requests pertaining to All Records Provided for 2018-8268.FDANonrulemaking
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Requests that the FDA to comply with FOIA law and post publicly on the FDA FOIA reading room all documents requested through various FOIA requests pertaining to FDA Employee Eric Nelson’s emails containing the key search term; AAFCO. This is for the date range of 05.01.2021-06.30.2021.FDANonrulemaking
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Requests that the FDA comply with FOIA law and post publicly on the FDA FOIA reading room all documents through various FOIA requests pertaining to FDA Employee Steven Solomon's calendar records This is for the date range of July 1 2018-March 07 2019.FDANonrulemaking
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Requesting that the FDA post publicly on the FDA FOIA reading room all documents requested through 3+ FOIA requests pertaining to HPP Being A Kill Step For Raw Pet Food Under FDA Regulatory Authority.FDANonrulemaking
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Request that the FDA take action on the issue of North Carolina Department of Agriculture misusing AFRPS grant funds to attend AAFCO meetingsFDANonrulemaking
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Requests that the FDA amend to the droperidol boxed warning (also called black box warning, or BBW), to remove the five sentences from the current boxed warningFDANonrulemaking
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Requests that the FDA amend the common and usual names of pet food ingredients, require pet food label disclosure of feed grade ingredients as ‘Feed Grade” within the ingredient panel and request the same Feed Grade disclosure to be required on pet food company websites and any promotional/advertising materials including but not limited to television advertising.FDANonrulemaking
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Request that the FDA amend the standard of identity for Pasteurized Orange Juice to reduce the minimum Brix levelFDANonrulemaking
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Requests that the FDA enforce the reclassification of Category III Sunscreen activities (insufficient data available to permit final classification) from the-over-the-counter (OTC) sunscreen monograph to Category II (Not Generally Recognized as safe & effective for human use) "OR" incorporate appropriate warning statements allowing consumers to understand the health risks associated with their useFDANonrulemaking
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Requests that the FDA take all administrative actions required for reclassification or the medical devices associated with Product Code OAY; FDA regulatory classification details of which as on May 17, 2019 - CLOSEDFDANonrulemaking
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Requests that the FDA determine whether MYSOLINE primidone Suspension 250 mg/5 mL approved under New Drug Application NDA number 010401 held by Nuro Pharma LLC has been voluntarily withdrawn for reasons of safety or effectivenessFDANonrulemaking
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Requests that the FDA issue, via regulation, changes to 21 CFR 868.5470, with proposed language providing that “hyperbaric chambers shall comply with the FDA’s recognized consensus standards for hyperbaric chambers, i.e. NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) and update the FDA’s recognized consensus.FDANonrulemaking
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75‐Day Premarket Notification for New Dietary Ingredients_2022FDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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