Dockets

Recently active federal rulemakings, soonest-closing first.

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Drug Repurposing for Unmet Medical Needs; Request for InformationFDANonrulemakingCloses Jun 12, 2026
1 document · 323 comments · 14 awaiting analysis
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) manufactured by Moderna TX Inc.FDANonrulemakingCloses Jun 18, 2026
1 document · 4 comments
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemakingCloses Jun 23, 2026
1 document · 2 comments
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a HearingFDANonrulemakingCloses Jun 30, 2026
1 document · 67 comments · 5 awaiting analysis
Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for CommentsFDANonrulemakingCloses Jun 30, 2026
1 document · 203 comments · 4 awaiting analysis
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for InformationFDANonrulemakingCloses Jun 30, 2026
1 document · 121 comments · 1 awaiting analysis
List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; NoticeFDANonrulemakingCloses Jul 1, 2026
1 document · 624 comments · 269 awaiting analysis
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and CommentsFDANonrulemakingCloses Jul 1, 2026
1 document · 16 comments
Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for CommentsFDANonrulemakingCloses Jul 1, 2026
1 document · 7 comments
Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and InformationFDARulemakingCloses Jul 16, 2026
1 document · 2 comments · 1 awaiting analysis
Specific Electronic Submissions Intended for FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, and other administrative record submissions) - Comments/Complaints are not to be submitted on this docket ID.FDANonrulemaking
1 document · 1 comment · 1 awaiting analysis
Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009FDANonrulemaking
1 document · 4,223 comments · 1,380 awaiting analysis
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
1 document · 2 comments
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
1 document · 1 comment · 1 awaiting analysis
Request that the FDA to revoke all BLA’s for every mRNA COVID-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standardsFDANonrulemaking
1 document · 4,827 comments · 1,356 awaiting analysis
Requests that the FDA Open a Docket, Hold a Part 15 Public Hearing Regarding the Off-Label Use of Estrogen in Natal Males for Gender Affirmation, and Consider Regulatory Action Including a Boxed Warning Under 21 C.F.R. § 201.80(e)FDANonrulemaking
1 document · 2,075 comments · 731 awaiting analysis
Requests that the FDA initiate rulemaking to establish a clear, enforceable regulatory definition and substantiation requirements for the animal-raising claim “pasture-raised” as applied to shell eggs from laying hens.FDANonrulemaking
1 document · 1,616 comments · 579 awaiting analysis
Requests that the FDA take the following measures to protect the public from mercury exposure and other risks caused by dental amalgam: (1) Ban dental amalgam, (2) Ban the use of dental amalgam at least in high-risk populations, including children, pregnant women, women who are planning to become pregnant, nursing women, people with neurological disease, people with impaired kidney functionFDANonrulemaking
1 document · 53 comments
Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibioticsFDANonrulemaking
1 document · 5 comments
Request that the FDA, acting through its Center for Veterinary Medicine ("CVM"), exercise its post-approval oversight authority to impose enforceable safe-use conditions for Librela (bedinvetmab injection) (NADA 141-562), a caninized monoclonal antibody approved for the control of pain associated with osteoarthritis in dogsFDANonrulemaking
1 document · 0 comments
Requests that the FDA amend 21 CFR § 610.13 by removing references to the Rabbit Pyrogen Test (RPT) and replacing them with language that supports the use of validated, non-animal, human-relevant pyrogen testing methods.FDANonrulemaking
2 documents · 0 comments
Requests that the FDA Mandate Specific Labeling Disclosure for Animal Secretions; Issue a Declaratory Ruling on "Misleading" Thresholds; Grant Reciprocal GRAS Status to Sterile Upcycled Biomass.FDANonrulemaking
2 documents · 0 comments
Requests that the FDA refrain from approving any ANDA submitted pursuant to an approved suitability petition under section 505(j)(2)(C) of the FD&C Act for dabrafenib mesylate capsules, 150 mg (EQ Base), unless and until the applicant has conducted and submitted to the FDA.FDANonrulemaking
24 documents · 0 comments
Request that the FDA grant Formal Authorization of Human-Compatible Food-Based Waste Substrates or the Revocation of Sanitary Endorsements for Commercial Feline AnalogsFDANonrulemaking
2 documents · 0 comments
Requests that the FDA issue a formal determination regarding the safety and sanitary classification of agricultural-derived products (e.g., corn, wheat, millet, soy) when used as substrates for animal waste versus human waste.FDANonrulemaking
2 documents · 0 comments
Solid Contents Statement on Canned Fruit & Vegetable ProductFDANonrulemaking
0 documents · 0 comments
Importation of Silicone Gel-Filled Breast ProsthesesFDANonrulemaking
0 documents · 0 comments
Safe Use of D&C Violet No. 2 as a Color AdditiveFDANonrulemaking
0 documents · 0 comments
Safe Use of Dried Fruit/Vegetable Juice Color AdditiveFDANonrulemaking
0 documents · 0 comments
Changes to Be Reported for Product & Establishment License Application; GuidanceFDANonrulemaking
0 documents · 0 comments
Decomposition & Histamine-Raw, Frozen Tuna & Mahi-Mahi; AvailableFDANonrulemaking
0 documents · 0 comments
Patent Extension Application for SERZONE® Patent No. 4,338,317FDANonrulemaking
0 documents · 0 comments
Safe Use of Ethylene Terephthalate-Isophthalate CopolymersFDANonrulemaking
0 documents · 0 comments
Safe Use of Polymethylsilsesquioxane as a Surface Lubricant or Anti-Blocking AgentFDANonrulemaking
0 documents · 0 comments
Safe Use of Polyaryletherketone ResinsFDANonrulemaking
0 documents · 0 comments
Safe Use of Peroxyacetic, Acetic & Hydrogen Peroxide AcidsFDANonrulemaking
0 documents · 0 comments
Rhizopus Oryzae Be Affirmed as (GRAS) as Human Food IngredientsFDANonrulemaking
0 documents · 0 comments
Partially Hydrolyzed Guar Gum Recognized as GRASFDANonrulemaking
0 documents · 0 comments
Nisin, Antimicrobial Agent in Sauces & Salad DressingsFDANonrulemaking
0 documents · 0 comments
Premarket Approval of VasoSeal Vascular Hemostasis DeviceFDANonrulemaking
0 documents · 0 comments
Proposal to Debar Amirul Islam; Notice of Opportunity for HearingFDANonrulemaking
0 documents · 0 comments
Protection of Human Subjects; Informed ConsentFDANonrulemaking
0 documents · 0 comments
Substances Approved Use in Preparation Meat/Poultry ProductsFDANonrulemaking
0 documents · 0 comments
Inapplicability of the Dietary Supplement Health & Education ActFDANonrulemaking
0 documents · 0 comments
Ephedrine Alkaloids: Reports of Adverse Events; AvailabilityFDANonrulemaking
0 documents · 0 comments
Quality/fill Container; Common or Unusual Name RegulationsFDANonrulemaking
0 documents · 0 comments
In Vitro Diagnostic Devices; Tier/Triage Management Initiative; Notice of Public Workshop & Public CommentsFDANonrulemaking
0 documents · 0 comments
Protection of Human Subjects; Informed ConsentFDANonrulemaking
0 documents · 0 comments
Opportunity for Hearing on Proposal to Withdraw 2 ANDA's & 1 AADAFDANonrulemaking
0 documents · 0 comments
Products Comprised of Living Autologous CellsFDANonrulemaking
0 documents · 0 comments