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Food and Drug Administration

175 documents across 49 days of the archive, 25 of them final rules. The five most recent days are below.

Dates this agency has set that have not yet arrived

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Comment deadlines and effective dates from anything this agency published in the archive, still ahead of 29 October 2026.

Dates set before this archive began are not here, and their absence is not evidence that none exist.

as_of

  1. today Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 Health and Human Services Department · Food and Drug Administration
  2. +1d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Health and Human Services Department · Food and Drug Administration
  3. +1d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Health and Human Services Department · Food and Drug Administration
  4. +4d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program Health and Human Services Department · Food and Drug Administration
  5. +5d Comments close Advancing Development of Botanical Drug Products; Request for Information Health and Human Services Department · Food and Drug Administration
  6. +11d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Health and Human Services Department · Food and Drug Administration
  7. +11d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications Health and Human Services Department · Food and Drug Administration
  8. +11d Comments close Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information Health and Human Services Department · Food and Drug Administration · Health Resources and Services Administration
  9. +11d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Health and Human Services Department · Food and Drug Administration
  10. +11d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements Health and Human Services Department · Food and Drug Administration
  11. +11d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Health and Human Services Department · Food and Drug Administration
  12. +12d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Health and Human Services Department · Food and Drug Administration
  13. +15d Comments close Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments Health and Human Services Department · Food and Drug Administration
  14. +15d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products Health and Human Services Department · Food and Drug Administration
  15. +15d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards Health and Human Services Department · Food and Drug Administration
  16. +15d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements Health and Human Services Department · Food and Drug Administration
  17. +15d Comments close Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate Health and Human Services Department · Food and Drug Administration
  18. +19d Comments close Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Health and Human Services Department · Food and Drug Administration
  19. +19d Comments close Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document Health and Human Services Department · Food and Drug Administration
  20. +19d Comments close Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  21. +20d Comments close Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  22. +22d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications Health and Human Services Department · Food and Drug Administration
  23. +22d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption Health and Human Services Department · Food and Drug Administration
  24. +22d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Health and Human Services Department · Food and Drug Administration
  25. +22d Comments close Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information Health and Human Services Department · Food and Drug Administration
  26. +25d Comments close Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  27. +25d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program Health and Human Services Department · Food and Drug Administration
  28. +26d Comments close Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Health and Human Services Department · Food and Drug Administration
  29. +27d Comments close Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments Health and Human Services Department · Food and Drug Administration
  30. +29d Comments close Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Health and Human Services Department · Food and Drug Administration

27 more beyond these.

28 October 2026 9 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published nine notices on October 28, 2026, including draft guidance on individualized genome editing products and IDE applications.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management." The draft guidance document provides recommendations for how an individualized human genome editing (GE) product that includes multiple product variants can be submitted in a single Biologics License Application (BLA). When finalized, this guidance will describe the FDA's current thinking on individualized GE products with respect to how to specify the extent of GE component variation in a BLA, how to add new product variants to the BLA after licensure, and related topics.

  • Comments close in 29 days

91 FR 67838FR Doc. 2026-21954official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to the current publicly available resources and associated content developed to support IDE electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for sponsors to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.

  • Comments close in 60 days

91 FR 67840FR Doc. 2026-21953official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs."

  • Comments close in 60 days

91 FR 67845FR Doc. 2026-21914official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 29 days

91 FR 67842FR Doc. 2026-21913official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of rapid response surveys to obtain data on safety information that supports quick turnaround decision making about potential safety problems or risk management solutions.

  • Comments close in 60 days

91 FR 67843FR Doc. 2026-21912official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EMCITATE (tiratricol), approved September 28, 2026, manufactured by Rare Thyroid Therapeutics International AB meets the criteria for a priority review voucher.

91 FR 67840FR Doc. 2026-21911official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ATEBRIOZ (Zilurgisertib)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ATEBRIOZ (zilurgisertib), approved September 25, 2026, manufactured by Incyte Corporation meets the criteria for a priority review voucher.

91 FR 67839FR Doc. 2026-21910official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)

The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that Bixlenvo (bictegravir and lenacapavir), tablets, approved August 27, 2026, meet the redemption criteria.

91 FR 67835FR Doc. 2026-21909official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection applicable to the electronic record signature provisions found in Agency regulations.

  • Comments close in 60 days

91 FR 67836FR Doc. 2026-21908official PDFfederalregister.gov

27 October 2026 2 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA published notices determining PEPCID RPD famotidine tablets were not withdrawn for safety reasons and announcing draft guidance on U.S.-origin statements for seafood labeling.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for famotidine) orally disintegrating tablets, 20 mg and 40 mg, if all other legal and regulatory requirements are met.

91 FR 67587FR Doc. 2026-21897official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "U.S.-Origin Statements on Seafood." The draft guidance, when finalized, will provide examples of U.S.-origin statements in seafood product labeling that FDA would consider to be truthful and not misleading.

  • Comments close in 60 days

91 FR 67588FR Doc. 2026-21838official PDFfederalregister.gov

26 October 2026 1 document

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration announced issuance of a priority review voucher for ISEMBYLD, a rare pediatric disease product approved September 11, 2026.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ISEMBYLD (apitegromab-mstn), approved September 11, 2026, manufactured by Scholar Rock, Inc., meets the criteria for a priority review voucher.

91 FR 67321FR Doc. 2026-21718official PDFfederalregister.gov

23 October 2026 7 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published five notices and two proposed rules on October 23, 2026.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on export certificates for FDA regulated products.

  • Comments close in 54 days

91 FR 66848FR Doc. 2026-21714official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with product jurisdiction and combination product regulations.

  • Comments close in 54 days

91 FR 66852FR Doc. 2026-21713official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

  • Comments close in 25 days

91 FR 66845FR Doc. 2026-21712official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO

The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and DAYVIGO. The original determinations were announced in the Federal Registers of August 10, 2026 (BRINSUPRI, DAYVIGO), August 17, 2026 (BIZENGRI), and September 9, 2026 (ANDEMBRY, ANZUPGO, ANKTIVA). Those notices correctly identified the dates on which the testing and approval phases began and ended but incorrectly stated the length of the regulatory review period due to calculation errors. No other changes are made.

91 FR 66851FR Doc. 2026-21711official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products. The guidance announced in this notice finalizes the draft guidance of the same title published on December 18, 2025.

91 FR 66851FR Doc. 2026-21679official PDFfederalregister.gov

Proposed RuleHealth and Human Services DepartmentFood and Drug Administration

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supply.

  • Comments close in 54 days

91 FR 66796FR Doc. 2026-21670official PDFfederalregister.gov

Proposed RuleHealth and Human Services DepartmentFood and Drug Administration

Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is titled "Chapter 12: Control of Chemical Hazards." This draft guidance is not final nor is it in effect at this time.

  • Comments close in 84 days

91 FR 66798FR Doc. 2026-21669official PDFfederalregister.gov

21 October 2026 1 document

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration announced availability of final guidance on regulatory considerations for prescription drug use-related software.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance finalizes the draft guidance of the same title issued on September 19, 2023.

91 FR 66561FR Doc. 2026-21516official PDFfederalregister.gov

Earlier

44 further days of this agency's activity are in the long-form archive, oldest to newest, on one page.

Everything Food and Drug Administration has published, 2026-08-10 to 2026-10-28 →

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