Medical Device User Fee Rates for Fiscal Year 2027
FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesUS Federal Register - FDA Notices
Regulation
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Type
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Microbiology Devices Panel: Pathogen-Agnostic Sequencing Advisory Committee Meeting and Public Docket
FDA announces advisory committee meeting and opens public docket to solicit input on pathogen-agnostic sequencing for emergency preparedness and response.
US Federal Register - FDA Notices · United StatesEstablishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
FDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesReauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
FDA invites public comment on proposed recommendations for reauthorizing the Biosimilar User Fee Act for fiscal years 2028–2032.
US Federal Register - FDA Notices · United StatesImproving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
HHS solicits input on regulatory pathways for deceased donor islet cell therapies for Type 1 diabetes treatment.
US Federal Register - FDA Notices · United StatesEvaluation of Therapeutic Equivalence; Guidance for Industry
FDA finalizes guidance on therapeutic equivalence evaluations and TE codes for multisource prescription drug products in the Orange Book.
US Federal Register - FDA Notices · United StatesFormal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Guidance for Industry
FDA finalizes guidance on formal meetings between the agency and sponsors or applicants of prescription drug and biological products.
US Federal Register - FDA Notices · United StatesBiosimilar User Fee Rates for Fiscal Year 2027
FDA announces biosimilar user fee rates for FY 2027 under the Biosimilar User Fee Amendments of 2022.
US Federal Register - FDA Notices · United StatesPrescription Drug User Fee Rates for Fiscal Year 2027
FDA announces prescription drug user fee rates for FY 2027 under PDUFA VII.
US Federal Register - FDA Notices · United StatesStatistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments
FDA establishes a public docket to collect feedback on statistical considerations for rare disease clinical trial design.
US Federal Register - FDA Notices · United StatesAnimal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027
FDA announces user fee rates and payment procedures for FY 2027 generic new animal drug applications under AGDUFA IV.
US Federal Register - FDA Notices · United StatesOver-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
FDA publishes user fee rates for OTC monograph drug manufacturers and submitters for fiscal year 2027 under OMUFA II.
US Federal Register - FDA Notices · United StatesGeneric Drug User Fee Rates for Fiscal Year 2027
FDA announces fiscal year 2027 fee rates for generic drug applications, facilities, and applicant programs under GDUFA III.
US Federal Register - FDA Notices · United StatesFood Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027
FDA announces FY 2027 annual and initial/renewal fee rates for accreditation bodies and certification bodies in the FSMA third-party certification program.
US Federal Register - FDA Notices · United StatesVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—2027 Southern Hemisphere Influenza Virus Vaccines
FDA announces a public advisory committee meeting and opens a docket for comments on 2027 Southern Hemisphere influenza virus vaccines.
US Federal Register - FDA Notices · United StatesFDA Recognized Consensus Standards: Modifications to Recognition List Number 066
FDA announces updates to its list of recognized consensus standards for medical device premarket review and conformity declarations.
US Federal Register - FDA Notices · United StatesReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
FDA invites public comment and holds a meeting on proposed recommendations for reauthorizing GDUFA for fiscal years 2028–2032.
US Federal Register - FDA Notices · United StatesButylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment Period
FDA reopens comment period for BHT safety and regulatory information request to allow stakeholders additional time for data submission.
US Federal Register - FDA Notices · United StatesDental Composite Resin Devices and Dental Curing Lights—Premarket Notification (510(k)) Submissions Guidances
FDA issues final guidance on 510(k) submission requirements for dental composite resin devices and dental curing lights, superseding 2005 and 2006 guidances.
US Federal Register - FDA Notices · United StatesInternational Drug Scheduling; Request for Comments on Clobromazolam, Cychlorphine, Desalkylgidazepam, Ethylbromazolam, Etomethazene, Spirochlorphine, Etomidate, and Medetomidine
FDA requests comments on abuse potential, medical usefulness, and trafficking of eight drug substances for international scheduling consideration.
US Federal Register - FDA Notices · United StatesAmending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Removal of Aminobenzoic Acid (PABA) and Trolamine Salicylate
FDA removes PABA and trolamine salicylate as permitted active ingredients in over-the-counter sunscreen drug products, finding them not generally recognized as safe and effective.
US Federal Register - FDA Notices · United StatesRequest for Nominations for Individuals and Consumer Organizations for FDA Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory ...
US Federal Register - FDA Notices · United StatesRequest for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting nominations for qualified individuals to serve as voting members of FDA's standing public advisory committees and panels (collectively, advisory committee...
US Federal Register - FDA Notices · United StatesProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
FDA announces availability of draft product-specific guidances on bioequivalence study design for abbreviated new drug applications.
US Federal Register - FDA Notices · United StatesMolecular and Clinical Genetics Panel Advisory Committee Meeting on GRAIL Galleri; Request for Comments
FDA announces public advisory committee meeting and opens docket for comments on GRAIL's Galleri multi-cancer early detection test.
US Federal Register - FDA Notices · United StatesAuthorization of Emergency Use of Allplex HSV-1&2/VZV/MPXV Assay In Vitro Diagnostic Device in Response to Mpox Outbreak
FDA issued Emergency Use Authorization for Allplex HSV-1&2/VZV/MPXV Assay for simultaneous detection and differentiation of monkeypox, herpes simplex, and varicella-zoster virus nucleic acids.
US Federal Register - FDA Notices · United StatesDermatologic and Ophthalmic Drugs Advisory Committee meeting on Atropine Sulfate Ophthalmic Solution 0.01% (NDA 219694)
FDA announces public advisory committee meeting and opens docket for comments on a new drug application for atropine sulfate ophthalmic solution.
US Federal Register - FDA Notices · United StatesJeffrey Thies: Final Debarment Order
FDA debars Jeffrey Thies for 10 years from importing or offering for import any drug into the United States for trafficking in counterfeit goods and aiding and abetting.
US Federal Register - FDA Notices · United StatesNaveed Aslam: Final Debarment Order
FDA permanently debars Naveed Aslam from providing services to persons with approved or pending drug product applications following felony conviction.
US Federal Register - FDA Notices · United StatesFHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
FDA withdraws approval of NDA 010401 for MYSOLINE primidone suspension 250 mg/5 mL held by FHTA LLC.
US Federal Register - FDA Notices · United StatesSanjay Kumar: Final Debarment Order
FDA debars Sanjay Kumar for 5 years from importing drugs into the United States following conviction for conspiracy to traffic in counterfeit goods.
US Federal Register - FDA Notices · United StatesRicardo Andres Acuna: Final Debarment Order
FDA permanently debars Ricardo Andres Acuna from providing services to persons with approved or pending drug product applications due to felony conviction.
US Federal Register - FDA Notices · United StatesAngela Anatilde Baquero: Final Debarment Order
FDA permanently debars Angela Anatilde Baquero from providing services to persons with approved or pending drug product applications following felony conviction.
US Federal Register - FDA Notices · United StatesDetermination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined osilodrostat 10 mg tablets were not withdrawn for safety or effectiveness reasons, permitting ANDA approvals.
US Federal Register - FDA Notices · United StatesDrugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date
FDA extends the effective date of the final resolution of Drug Efficacy Study Implementation 7661 for estrogen-androgen fixed-combination products to November 4, 2026.
US Federal Register - FDA Notices · United StatesDetermination That SULFADIAZINE Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined sulfadiazine 500 mg tablet was not withdrawn for safety or effectiveness reasons, permitting ANDA approvals.
US Federal Register - FDA Notices · United StatesRahim Shafa; Denial of Hearing; Final Debarment Order
FDA permanently debars Dr. Rahim Shafa from providing services to persons with approved or pending drug applications and debars him for 20 years from importing drugs into the United States, based on felony convictions.
US Federal Register - FDA Notices · United StatesIssuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)
FDA awards priority review voucher to Ultragenyx Pharmaceutical for approved rare pediatric disease product GENGLYCOS.
US Federal Register - FDA Notices · United StatesDetermination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY
FDA determined the regulatory review period for ANDEMBRY to support patent extension application to the USPTO.
US Federal Register - FDA Notices · United StatesDetermination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination becau...
US Federal Register - FDA Notices · United StatesDetermination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO
FDA determined the regulatory review period for ANZUPGO human drug product for patent extension purposes.
US Federal Register - FDA Notices · United StatesDetermination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined sucralfate oral suspension was not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined NAMENDA tablets were not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination That CABAZITAXEL Solution (Injection), 60 Milligrams/6 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined cabazitaxel solution was not withdrawn for safety or effectiveness reasons, enabling ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined LASIX furosemide tablets were not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined OZOBAX baclofen oral solution was not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination That PHENAPHEN WITH CODEINE NO. 3 and NO. 4 Were Not Withdrawn for Reasons of Safety or Effectiveness
FDA determined two acetaminophen-codeine formulations were not withdrawn for safety or effectiveness reasons, enabling ANDA approvals.
US Federal Register - FDA Notices · United StatesAuthorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm
FDA issued three Emergency Use Authorizations for animal products to prevent and treat New World screwworm infestations in cattle, horses, swine, sheep, deer, dogs, cats, and kittens.
US Federal Register - FDA Notices · United StatesDetermination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined flurbiprofen tablets 50 mg and 100 mg were not withdrawn for safety or effectiveness reasons, permitting ANDA approvals.
US Federal Register - FDA Notices · United StatesDetermination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination beca...
US Federal Register - FDA Notices · United States
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