Dockets

Recently active federal rulemakings, soonest-closing first.

Open for comment

FDA ▾

Requests that the FDA recognize Auryxia's regulatory exclusivity, require ANDAs for generic versions of Auryxia to be supported with in vivo bioequivalence (BE) data to address Auryxia's systemic effects, and data showing qualitative and quantitative sameness with regards to the major ions and counterions found in Auryxia's active moietyFDANonrulemaking
0 documents · 0 comments
Requests that the FDA remove the boxed warning from Ultrasound Contrast Agents product labels.FDANonrulemaking
0 documents · 0 comments
Request FDA to refrain from receiving any ANDA that references Imvexxy (NDA 208564) unless, for each strength that is Q1/Q2 and Q3 similar to ImvexxyFDANonrulemaking
0 documents · 0 comments
Laser Light ShowFDANonrulemaking
0 documents · 0 comments
Request for VarianceFDANonrulemaking
0 documents · 0 comments
Laser Light ShowFDANonrulemaking
0 documents · 0 comments
Laser Light ShowFDANonrulemaking
0 documents · 0 comments
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Instructions for Use -- Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products -- Content and Format; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Population Pharmacokinetics; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products- Questions and Answers; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
DAB Civil Money Penalty; M. M. Fowler Inc. d/b/a Family Fare 396; CLOSED 09/02/2025FDANonrulemaking
0 documents · 0 comments
DAB Civil Money Penalty; H and B Gas Inc. d/b/a Quik Mart / Citgo; CLOSED 09/22/2025FDANonrulemaking
0 documents · 0 comments
Modified Risk Tobacco Product Applications for VLN™ King and VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc.FDANonrulemaking
0 documents · 0 comments
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for CommentsFDANonrulemaking
0 documents · 0 comments
Consideration of Benefit-Risk Approaches for Weight-Loss DevicesFDANonrulemaking
0 documents · 0 comments
Requests that the FDA assign a Therapeutic Equivalance Evaluation Code ("TE Code") for the company's Vancomycin Injection, 500 mg/100 mL and 1 g/200 mLFDANonrulemaking
0 documents · 0 comments
Requests Commissioner of FDA to take all administrative actions required for reclassification of medical devices associated with Product Code NCD; reclassification of Product Code NCD from Class III to Class II subject to 510k pre-market notificationFDANonrulemaking
0 documents · 0 comments
Requesting that the FDA permit the filing of an Abbreviated New Drug Application for a proposed drug product that has the same active ingredient, same strength, and is expected to have the same therapeutic effect as Approved Drug Products with Therapeutic Equivalence Evaluations; CLOSEDFDANonrulemaking
0 documents · 0 comments
Laser Light ShowFDANonrulemaking
0 documents · 0 comments
Laser Light ShowFDANonrulemaking
0 documents · 0 comments
Submitting Comments on Guidance Documents Issued by The Center For Devices and Radiological Health (CDRH)FDANonrulemaking
0 documents · 0 comments
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Center for Biologics Evaluation and Research (CBER): COVID-19FDANonrulemaking
0 documents · 0 comments
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Cannabidiol (CBD) Enforcement Policy; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Guidance for Industry: Food Additive Petition Expedited ReviewFDANonrulemaking
0 documents · 0 comments
Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery ProductsFDANonrulemaking
0 documents · 0 comments
Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; AvailabilityFDANonrulemaking
0 documents · 0 comments
Patent Term Extension Application for MONOFERRIC (ferric derisomaltose), Patent No. 8,815,301FDANonrulemaking
0 documents · 0 comments
Patent Term Extension Application for MONOFERRIC (ferric derisomaltose), Patent No. 10,414,831FDANonrulemaking
0 documents · 0 comments
Patent Term Extension Application for PHEXXI® (l-lactic acid, citric acid, and potassium bitartrate), Patent No. 6,706,276FDANonrulemaking
0 documents · 0 comments
Patent Term Extension for EXEM FOAM, Patent No. 9,034,300FDANonrulemaking
0 documents · 0 comments
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth StimulatorsFDANonrulemaking
0 documents · 0 comments
Revocation of Methods of Analysis RegulationFDARulemaking
0 documents · 0 comments
Authorization of Emergency Use of Certain Medical Devices during COVID-19; AvailabilityFDANonrulemaking
0 documents · 0 comments
Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID-19 Pandemic; AvailabilityFDANonrulemaking
0 documents · 0 comments
Requests that the FDA refrain from receiving or approving any ANDA that references Imvexxy (estradiol vaginal inserts), NDA #208564, unless the shape of the vaginal insert is the same teardrop shape as that of Imvexxy.FDANonrulemaking
0 documents · 0 comments
Request the FDA to recognize recombinant Factor C (rFC) as a method equivalent to existingcompendial methods of bacterial endotoxin testing [Limulus amoebocyte lysate (LAL) and Tachypleus tridentatus lysate (TAL)] and to amend the biologics regulations using Executive Orders 13771 and 13777FDANonrulemaking
0 documents · 0 comments
Request that the FDA determine whether BACTROBAN® (mupirocin calcium) Nasal Ointment, 2%, approved under NDA 050703 (held by GlaxoSmithKline), has been discontinued from sale for safety or efficacy reasonsFDANonrulemaking
0 documents · 0 comments
Requests that the FDA define key terms essential to consider the cumulative effect of a food additive, food contact substance, generally recognized as safe substance, or color additive, taking into account any chemically- or pharmacologically-related substances in the diet, when assessing safety as required by law.FDANonrulemaking
0 documents · 0 comments
Requests that the FDA recall on identified lots of Acetazolamide tor injection on the basis that, due to under-potency and excessive impurities in some vials, these drugs are adulterated under Section 501 of the FDCA (21 U.S.C. § 351) and misbranded under Section 502 of the FDCA (21 U.S.C. § 352); conduct examinations and investigation provide information to the public promulgate regulations.FDANonrulemaking
0 documents · 0 comments