coverage from
i
What that date means
Coverage begins on 2026-08-10, which is when this archive started holding
Federal Register issues — not when the agency started publishing.
Anything earlier is absent from this page, and its absence is not evidence.
The Food and Drug Administration published four notices and one proposed rule on August 10, 2026, including determinations on baclofen oral solution and patent extension periods.
The FDA announced availability of final guidance for industry on minimizing biological hazards in ready-to-eat fresh-cut produce.
The Food and Drug Administration published notices announcing a hearing on a methylphenidate tablet approval withdrawal proposal and finalizing guidance on formal meetings with drug sponsors.
The Food and Drug Administration published two proposed rules on device classification and one final rule reclassifying in situ hybridization test systems, along with six notices regarding information collections and guidance.
The FDA published draft guidance on abbreviated drug application pathways and announced a public workshop on testosterone use in menopausal women.
FDA published three proposed rules on color additive petitions for gardenia blue, carrot oil, and safflower extract, and one final rule permitting chromium DL-methionine chelate in animal feed.
The FDA published four notices renewing two advisory committees and releasing draft and final guidance documents on potency assessment and cellular and gene therapy product development.
The Food and Drug Administration announced renewal of the Oncologic Drugs Advisory Committee for an additional two years until September 1, 2028.
The Food and Drug Administration published three notices regarding medical device standards recognition, product-specific drug guidances, and therapeutic equivalence evaluation guidance.
The FDA extended the effective date of its final resolution regarding estrogen-androgen fixed-combination drug products to November 4, 2026.
The Food and Drug Administration published six notices regarding information collection activities and draft guidance for animal drug compounding.
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.
The FDA published a notice determining that NAMENDA memantine hydrochloride tablets were not withdrawn for safety or effectiveness reasons.
The FDA determined that Phenaphen with Codeine No. 3 and No. 4 oral capsules were not withdrawn for safety or effectiveness reasons.
The FDA published a notice requesting information on advancing botanical drug product development, with comments due November 3, 2026.
The Food and Drug Administration published seven notices on September 9, 2026, including guidance on neonatal parenteral nutrition compounding and patent extension determinations.
The FDA published ten documents including one proposed rule withdrawing a food additive petition, one notice establishing a fiscal year 2027 priority review voucher fee rate, and eight rules classifying medical devices.
The FDA classified cardiovascular machine learning-based notification software as class II medical devices and amended sunscreen monograph requirements.
The Food and Drug Administration submitted a proposed information collection on customer service satisfaction surveys to the Office of Management and Budget for review.
The FDA submitted a collection of information on biological product deviations for OMB review and announced a Microbiology Devices Panel meeting on pathogen-agnostic sequencing.
The Food and Drug Administration published three draft guidance documents for electronic medical device submissions, interchangeable biosimilar development, and veterinary monoclonal antibody safety evaluation.
The Food and Drug Administration published five notices on September 21, 2026, regarding information collection activities and a chemistry, manufacturing, and controls pilot program.
The Food and Drug Administration debarred Sanjay Kumar for five years from importing drugs into the United States following his felony conviction for conspiracy to traffic in counterfeit goods.
The Food and Drug Administration published a notice opening a public docket to solicit input on regulating deceased donor islet cells and cell products for Type 1 diabetes treatment.
The Food and Drug Administration published four notices determining sulfadiazine tablet was not withdrawn for safety reasons, withdrawing approval of primidone suspension, and requesting comment on information collection activities.
The Food and Drug Administration published a correction regarding its determination that Oxandrin tablets were withdrawn from sale for safety or effectiveness reasons.
The Food and Drug Administration published notices requesting comment on information collection activities for pesticide residue policy and medical device adverse events.
The Food and Drug Administration published nine notices, three rules, and one proposed rule on October 9, 2026.
- Notice Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)↗ 2026-20769
- Notice Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements↗ 2026-20768
- Notice Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC↗ 2026-20766
- Notice Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use↗ 2026-20765
- Notice Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness↗ 2026-20764
- Notice Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications↗ 2026-20762
- Notice Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams↗ 2026-20758
- Notice Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction↗ 2026-20730
- Rule Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens↗ 2026-20727
- Rule Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use↗ 2026-20726
- Rule Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit↗ 2026-20725
- Proposed Rule Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability↗ 2026-20721
- Notice Challenges and Solutions in Lot-Level Food Traceability; Public Meeting↗ 2026-20720
The FDA issued a final rule permitting salt substitutes in standardized foods to reduce sodium content, effective December 14, 2026, and released final guidance on postapproval manufacturing changes to biosimilar products.
The Food and Drug Administration published a final rule permitting chromium propionate as a food additive for laying hens and breeder chickens.
The Food and Drug Administration issued four Emergency Use Authorizations for animal drugs to prevent and treat New World screwworm infestations in livestock, wildlife, and pets.
The Food and Drug Administration published three notices on electronic submissions standards and a rare disease framework initiative.
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mcp.downstream.sh as an MCP server in Claude, ChatGPT, or any client that speaks the
protocol — no key, no account — then paste this:
Using the Downstream MCP server at mcp.downstream.sh, call whats_new_since with agency "Food and Drug Administration" since 2026-08-10, then tell me what this agency has been working on and which of its deadlines are still open.
Reaches whats_new_since. The response carries its own citations
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