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Food and Drug Administration

61 documents across 19 days of the archive, 3 of them final rules. The five most recent days are below.

Dates this agency has set that have not yet arrived

What is in this list

Comment deadlines and effective dates from anything this agency published in the archive, still ahead of 4 September 2026.

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

as_of

  1. +12d Takes effect Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product Health and Human Services Department · Food and Drug Administration
  2. +12d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Health and Human Services Department · Food and Drug Administration
  3. +14d Comments close International Association of Color Manufacturers; Filing of Color Additive Petition Health and Human Services Department · Food and Drug Administration
  4. +14d Comments close Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate Health and Human Services Department · Food and Drug Administration
  5. +24d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs Health and Human Services Department · Food and Drug Administration
  6. +24d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees Health and Human Services Department · Food and Drug Administration
  7. +26d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form Health and Human Services Department · Food and Drug Administration
  8. +35d Comments close Radiology Devices; Reclassification of Digital Breast Tomosynthesis System Health and Human Services Department · Food and Drug Administration
  9. +39d Comments close Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  10. +42d Comments close Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Health and Human Services Department · Food and Drug Administration
  11. +42d Comments close Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Health and Human Services Department · Food and Drug Administration
  12. +42d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food Health and Human Services Department · Food and Drug Administration
  13. +42d Comments close Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Health and Human Services Department · Food and Drug Administration
  14. +42d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries Health and Human Services Department · Food and Drug Administration
  15. +43d Comments close Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Health and Human Services Department · Food and Drug Administration
  16. +45d Comments close Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  17. +49d Comments close Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Health and Human Services Department · Food and Drug Administration
  18. +52d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Health and Human Services Department · Food and Drug Administration
  19. +53d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Health and Human Services Department · Food and Drug Administration
  20. +53d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Health and Human Services Department · Food and Drug Administration
  21. +53d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Health and Human Services Department · Food and Drug Administration
  22. +56d 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
  23. +56d 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
  24. +60d Comments close Advancing Development of Botanical Drug Products; Request for Information Health and Human Services Department · Food and Drug Administration
  25. +75d Comments close Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  26. +84d 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. +88d Comments close Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  28. +96d Comments close Substances Generally Recognized as Safe Health and Human Services Department · Food and Drug Administration
  29. +157d Comments close Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI Health and Human Services Department · Food and Drug Administration
  30. +157d Comments close Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO Health and Human Services Department · Food and Drug Administration

4 September 2026 1 document

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

The FDA published a notice requesting information on advancing botanical drug product development, with comments due November 3, 2026.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Advancing Development of Botanical Drug Products; Request for Information

The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders' perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

  • Comments close in 60 days

91 FR 56887FR Doc. 2026-18133official PDFfederalregister.gov

3 September 2026 1 document

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

The FDA determined that Phenaphen with Codeine No. 3 and No. 4 oral capsules were not withdrawn for safety or effectiveness reasons.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 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 PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met.

91 FR 56654FR Doc. 2026-18023official PDFfederalregister.gov

2 September 2026 6 documents

No sentence for this date — either it has not been generated yet, or it was withheld by the fidelity gate.

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

91 FR 56455FR Doc. 2026-17968official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA's current thinking. FDA is also withdrawing the guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling" (May 2003), which formerly provided FDA's thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling.

  • Comments close in 88 days

91 FR 56449FR Doc. 2026-17961official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions." These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. These guidances supersede the guidances "Dental Composite Resin Devices-- Premarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights--Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions.

91 FR 56452FR Doc. 2026-17933official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)

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 GENGLYCOS (parisglasgene brecaparvovec-opnr), approved on August 19, 2026, manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.

91 FR 56456FR Doc. 2026-17932official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.

91 FR 56454FR Doc. 2026-17928official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.

91 FR 56451FR Doc. 2026-17927official PDFfederalregister.gov

1 September 2026 1 document

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

The FDA published a notice determining that NAMENDA memantine hydrochloride tablets were not withdrawn for safety or effectiveness reasons.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.

91 FR 56149FR Doc. 2026-17812official PDFfederalregister.gov

31 August 2026 5 documents

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

FDA issued three Emergency Use Authorizations for animal drugs to prevent and treat New World screwworm infestations in cattle, horses, swine, sheep, deer, dogs, cats, and kittens.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in dairy cattle, horses, swine, sheep, and deer. FDA has issued one EUA for an animal product as requested by Felix Pharmaceuticals Pvt. Ltd. for the treatment of infestations caused by NWS myiasis in dogs, puppies, cats, and kittens. FDA has issued one EUA for an animal product as requested by Alberta Vet Labs Ltd for the short-term prevention of infestations caused by NWS myiasis in horses. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

  • Takes effect 108 days ago

91 FR 55861FR Doc. 2026-17719official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form

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 26 days

91 FR 55856FR Doc. 2026-17677official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

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

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 information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

  • Comments close in 56 days

91 FR 55857FR Doc. 2026-17676official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections

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 reports of removals and corrections for medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH).

  • Comments close in 56 days

91 FR 55859FR Doc. 2026-17675official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Rahim Shafa; Denial of Hearing; Final Debarment Order

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.

91 FR 55886FR Doc. 2026-17659official PDFfederalregister.gov

Earlier

14 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 2026-09-04 →

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