Dockets

Recently active federal rulemakings, soonest-closing first.

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Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary MedicineFDANonrulemaking
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Tobacco Retailers on Tobacco Retailer Training ProgramsFDANonrulemaking
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Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed; AvailabilityFDANonrulemaking
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Proposal to Debar/Notice of Opportunity for Hearing for Ray NathanFDANonrulemaking
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ANDA Suitability for Duloxetine HCI Delayed-Release Capsules, 40 mg - CLOSEDFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic ActFDANonrulemaking
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Applying Human Factors and Usability Engineering to Medical DevicesFDANonrulemaking
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Scientific Considerations in Demonstrating Biosimilarity to a Reference ProductFDANonrulemaking
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Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009FDANonrulemaking
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Information Required in Prior Notice of Imported FoodFDARulemaking
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Animal Generic Drug User Fee Act; Public MeetingFDANonrulemaking
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Animal Drug User Fee Act; Public MeetingFDANonrulemaking
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FDA to Require That it Will be Mandatory on all Packages Food Items "May Contain" and/or be Manufactured in a Facility With (Allergen)" Statement be Included as Part of the Ingredient List or Will be Required to Appear Somewhere on the PackageFDANonrulemaking
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Amend the Standard of Identity for Canned TunaFDANonrulemaking
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Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco ProductsFDANonrulemaking
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Questions and Answers Regarding Food Facility RegistrationFDARulemaking
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Draft Guidance for Industry on Certification of Designated Medical Gases; AvailabilityFDANonrulemaking
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Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket, Request for CommentsFDANonrulemaking
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Food and Drug User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Years Proposed Guidance DevelopmentsFDANonrulemaking
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Food Labeling: Revision of the Nutrition and Supplement Facts LabelsFDARulemaking
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Refrain From Approving Any ANDA Referencing Testopel Unless The Conditions Specified in The Petition Are SatisfiedFDANonrulemaking
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Determine That an Abbreviated New Drug Application (ANDA) Oxycodone Hydrochloride Extended-Release Capsules may be Submitted and be Considered Bioequivalent to the Reference Listed Drug (RLD) Oxycontin® (Oxycodone Hydrochloride Controlled-Release) TabletsFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use Qs & AsFDANonrulemaking
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Expedited Programs for Serious Conditions--Drugs and BiologicsFDANonrulemaking
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Global Unique Device Identification Database (GUDID); Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Guidance for Industry on General Clinical Pharmacology Consideration for Pediatric Studies for Drugs and Biological ProductsFDANonrulemaking
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Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; AvailabilityFDANonrulemaking
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Draft Guidance for Industry on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA; AvailabilityFDANonrulemaking
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Tobacco Product Manufacturing Practice; Establishment of a Public DocketFDARulemaking
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Request to Promulgate a Series of Regulations to Protect U.S. Consumers From Cesium 134 and Cesium 137 ContaminationFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Voluntary Sodium Reduction Goals: Target Mean and Recommended Maximum Concentrations for Sodium in Commercially Processed, Packaged, and Prepared FoodsFDANonrulemaking
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Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic DevicesFDANonrulemaking
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Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification RequirementsFDANonrulemaking
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Patent Term Extension Application for lNJECTAFER® (ferric carboxymaltose) Patent No. 7,612,109FDANonrulemaking
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Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco ProductsFDARulemaking
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General Wellness Products Draft Guidance for Industry and Food and DrugFDANonrulemaking
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Brain-Computer Interface Devices for Patients with Paralysis and Amputation; Public Workshop; Request for CommentsFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Individual Patient Expanded Access ApplicationsFDARulemaking
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Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device LabelingFDANonrulemaking
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Rare Diseases: Common Issues in Drug DevelopmentFDARulemaking
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Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActFDANonrulemaking
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List of Highest Priority Devices for Human Factors ReviewFDARulemaking
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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and DevelopmentFDANonrulemaking
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Compounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketFDARulemaking
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Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human UseFDARulemaking
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