# Food and Drug Administration — the long-form archive

Everything Food and Drug Administration has published while this archive has been running: 61 documents across 19 days, oldest first.

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.

[HTML](https://downstream.sh/daily/agency/food-and-drug-administration/archive.html) · [the last five days](https://downstream.sh/daily/agency/food-and-drug-administration/index.md)

## 10 August 2026 — 5 documents

> 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.

- **Notice** [Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/08/10/2026-16248/determination-that-ozobax-baclofen-oral-solution-5-milligrams5-milliliters-was-not-withdrawn-from) · `2026-16248`
- **Notice** [Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI](https://www.federalregister.gov/documents/2026/08/10/2026-16247/determination-of-regulatory-review-period-for-purposes-of-patent-extension-brinsupri) · `2026-16247`
- **Notice** [Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO](https://www.federalregister.gov/documents/2026/08/10/2026-16246/determination-of-regulatory-review-period-for-purposes-of-patent-extension-dayvigo) · `2026-16246`
- **Notice** [Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri](https://www.federalregister.gov/documents/2026/08/10/2026-16245/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting) · `2026-16245`
- **Proposed Rule** [Radiology Devices; Reclassification of Digital Breast Tomosynthesis System](https://www.federalregister.gov/documents/2026/08/10/2026-16209/radiology-devices-reclassification-of-digital-breast-tomosynthesis-system) · `2026-16209`

## 11 August 2026 — 2 documents

- **Notice** [Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments](https://www.federalregister.gov/documents/2026/08/11/2026-16353/reauthorization-of-the-generic-drug-user-fee-amendments-public-meeting-request-for-comments) · `2026-16353`
- **Proposed Rule** [Substances Generally Recognized as Safe](https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe) · `2026-16296`

## 12 August 2026 — 1 document

> The FDA announced availability of final guidance for industry on minimizing biological hazards in ready-to-eat fresh-cut produce.

- **Rule** [Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/12/2026-16420/guide-to-minimize-biological-hazards-in-ready-to-eat-fresh-cut-produce-guidance-for-industry) · `2026-16420`

## 13 August 2026 — 2 documents

> 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.

- **Notice** [Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets](https://www.federalregister.gov/documents/2026/08/13/2026-16536/kremers-urban-pharmaceuticals-inc-grant-of-hearing-request-regarding-a-proposal-to-withdraw-approval) · `2026-16536`
- **Notice** [Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/13/2026-16452/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-applicants-of-prescription) · `2026-16452`

## 14 August 2026 — 4 documents

- **Notice** [Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/08/14/2026-16666/determination-that-ansaid-flurbiprofen-tablets-50-milligrams-and-100-milligrams-were-not-withdrawn) · `2026-16666`
- **Notice** [Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments](https://www.federalregister.gov/documents/2026/08/14/2026-16650/reauthorization-of-the-prescription-drug-user-fee-act-public-meeting-request-for-comments) · `2026-16650`
- **Notice** [Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/08/14/2026-16648/determination-that-lasix-furosemide-tablets-20-milligrams-40-milligrams-and-80-milligrams-were-not) · `2026-16648`
- **Notice** [Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry) · `2026-16638`

## 17 August 2026 — 9 documents

> 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.

- **Proposed Rule** [Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments](https://www.federalregister.gov/documents/2026/08/17/2026-16729/medical-devices-classification-of-accessories-distinct-from-other-devices-proposed-list-of) · `2026-16729`
- **Proposed Rule** [Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer](https://www.federalregister.gov/documents/2026/08/17/2026-16728/gastroenterology-urology-devices-reclassification-of-diagnostic-endoscopic-light-source-systems-to) · `2026-16728`
- **Rule** [Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product](https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with) · `2026-16727`
- **Notice** [Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals](https://www.federalregister.gov/documents/2026/08/17/2026-16716/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals) · `2026-16716`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements](https://www.federalregister.gov/documents/2026/08/17/2026-16715/agency-information-collection-activities-proposed-collection-comment-request-investigational-new) · `2026-16715`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food](https://www.federalregister.gov/documents/2026/08/17/2026-16714/agency-information-collection-activities-proposed-collection-comment-request-third-party-disclosure) · `2026-16714`
- **Notice** [Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI](https://www.federalregister.gov/documents/2026/08/17/2026-16713/determination-of-regulatory-review-period-for-purposes-of-patent-extension-bizengri) · `2026-16713`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries](https://www.federalregister.gov/documents/2026/08/17/2026-16712/agency-information-collection-activities-proposed-collection-comment-request-imports-and-electronic) · `2026-16712`
- **Notice** [Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/17/2026-16711/type-vii-veterinary-master-file-for-research-and-development-and-risk-reviews-guidance-for-industry) · `2026-16711`

## 18 August 2026 — 2 documents

> The FDA published draft guidance on abbreviated drug application pathways and announced a public workshop on testosterone use in menopausal women.

- **Notice** [Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/18/2026-16837/determining-whether-to-submit-an-anda-or-a-505b2-application-draft-guidance-for-industry) · `2026-16837`
- **Notice** [Testosterone Use in Menopausal Women; Public Workshop; Request for Comments](https://www.federalregister.gov/documents/2026/08/18/2026-16829/testosterone-use-in-menopausal-women-public-workshop-request-for-comments) · `2026-16829`

## 19 August 2026 — 4 documents

> 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.

- **Proposed Rule** [Gardenia Blue Interest Group; Filing of Color Additive Petition](https://www.federalregister.gov/documents/2026/08/19/2026-16944/gardenia-blue-interest-group-filing-of-color-additive-petition) · `2026-16944`
- **Proposed Rule** [International Association of Color Manufacturers; Filing of Color Additive Petition](https://www.federalregister.gov/documents/2026/08/19/2026-16943/international-association-of-color-manufacturers-filing-of-color-additive-petition) · `2026-16943`
- **Rule** [Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate](https://www.federalregister.gov/documents/2026/08/19/2026-16942/food-additives-permitted-in-feed-and-drinking-water-of-animals-chromium-dl-methionine-chelate) · `2026-16942`
- **Proposed Rule** [GNT USA, LLC.; Filing of Color Additive Petition](https://www.federalregister.gov/documents/2026/08/19/2026-16939/gnt-usa-llc-filing-of-color-additive-petition) · `2026-16939`

## 20 August 2026 — 4 documents

> 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.

- **Notice** [Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal](https://www.federalregister.gov/documents/2026/08/20/2026-16999/advisory-committee-cardiovascular-and-renal-drugs-advisory-committee-renewal) · `2026-16999`
- **Notice** [Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal](https://www.federalregister.gov/documents/2026/08/20/2026-16998/advisory-committee-endocrinologic-and-metabolic-drugs-advisory-committee-renewal) · `2026-16998`
- **Notice** [Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/20/2026-16960/potency-assessment-of-active-immunotherapy-products-draft-guidance-for-industry-availability) · `2026-16960`
- **Notice** [Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/20/2026-16959/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products-final-guidance) · `2026-16959`

## 21 August 2026 — 1 document

> The Food and Drug Administration announced renewal of the Oncologic Drugs Advisory Committee for an additional two years until September 1, 2028.

- **Notice** [Advisory Committee; Oncologic Drugs Advisory Committee; Renewal](https://www.federalregister.gov/documents/2026/08/21/2026-17084/advisory-committee-oncologic-drugs-advisory-committee-renewal) · `2026-17084`

## 24 August 2026 — 3 documents

> The Food and Drug Administration published three notices regarding medical device standards recognition, product-specific drug guidances, and therapeutic equivalence evaluation guidance.

- **Notice** [Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066](https://www.federalregister.gov/documents/2026/08/24/2026-17229/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized) · `2026-17229`
- **Notice** [Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability](https://www.federalregister.gov/documents/2026/08/24/2026-17222/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability) · `2026-17222`
- **Notice** [Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/24/2026-17215/evaluation-of-therapeutic-equivalence-guidance-for-industry-availability) · `2026-17215`

## 26 August 2026 — 3 documents

- **Notice** [Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/08/26/2026-17401/determination-that-cabazitaxel-cabazitaxel-solution-injection-60-milligrams6-milliliters-10) · `2026-17401`
- **Notice** [International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments](https://www.federalregister.gov/documents/2026/08/26/2026-17380/international-drug-scheduling-single-convention-on-narcotic-drugs-convention-on-psychotropic) · `2026-17380`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health](https://www.federalregister.gov/documents/2026/08/26/2026-17377/agency-information-collection-activities-proposed-collection-comment-request-allegations-of) · `2026-17377`

## 27 August 2026 — 1 document

> The FDA extended the effective date of its final resolution regarding estrogen-androgen fixed-combination drug products to November 4, 2026.

- **Notice** [Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661](https://www.federalregister.gov/documents/2026/08/27/2026-17498/drugs-for-human-use-drug-efficacy-study-implementation-estrogen-androgen-fixed-combination-drug) · `2026-17498`

## 28 August 2026 — 6 documents

> The Food and Drug Administration published six notices regarding information collection activities and draft guidance for animal drug compounding.

- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery](https://www.federalregister.gov/documents/2026/08/28/2026-17605/agency-information-collection-activities-proposed-collection-comment-request-qualitative-feedback-on) · `2026-17605`
- **Notice** [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs](https://www.federalregister.gov/documents/2026/08/28/2026-17603/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) · `2026-17603`
- **Notice** [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](https://www.federalregister.gov/documents/2026/08/28/2026-17601/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) · `2026-17601`
- **Notice** [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](https://www.federalregister.gov/documents/2026/08/28/2026-17599/agency-information-collection-activities-proposed-collection-comment-request-food-canning) · `2026-17599`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration](https://www.federalregister.gov/documents/2026/08/28/2026-17598/agency-information-collection-activities-proposed-collection-comment-request-focus-groups-and) · `2026-17598`
- **Notice** [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](https://www.federalregister.gov/documents/2026/08/28/2026-17580/compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered) · `2026-17580`

## 31 August 2026 — 5 documents

> 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.

- **Notice** [Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability](https://www.federalregister.gov/documents/2026/08/31/2026-17719/authorization-of-emergency-use-for-three-animal-drugs-for-the-prevention-and-treatment-of-new-world) · `2026-17719`
- **Notice** [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form](https://www.federalregister.gov/documents/2026/08/31/2026-17677/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) · `2026-17677`
- **Notice** [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](https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human) · `2026-17676`
- **Notice** [Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections](https://www.federalregister.gov/documents/2026/08/31/2026-17675/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-reports) · `2026-17675`
- **Notice** [Rahim Shafa; Denial of Hearing; Final Debarment Order](https://www.federalregister.gov/documents/2026/08/31/2026-17659/rahim-shafa-denial-of-hearing-final-debarment-order) · `2026-17659`

## 1 September 2026 — 1 document

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

- **Notice** [Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/09/01/2026-17812/determination-that-namenda-memantine-hydrochloride-tablets-5-milligrams-and-10-milligrams-were-not) · `2026-17812`

## 2 September 2026 — 6 documents

- **Notice** [Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness](https://www.federalregister.gov/documents/2026/09/02/2026-17968/determination-that-carafate-sucralfate-oral-suspension-1-gram10-milliliters-was-not-withdrawn-from) · `2026-17968`
- **Notice** [Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/09/02/2026-17961/pharmacokinetics-in-patients-with-impaired-hepatic-function-study-design-data-analysis-and-impact-on) · `2026-17961`
- **Notice** [Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability](https://www.federalregister.gov/documents/2026/09/02/2026-17933/dental-composite-resin-devices-and-dental-curing-lights-premarket-notification-510k-submissions) · `2026-17933`
- **Notice** [Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)](https://www.federalregister.gov/documents/2026/09/02/2026-17932/issuance-of-priority-review-voucher-rare-pediatric-disease-product-genglycos-parisglasgene) · `2026-17932`
- **Notice** [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](https://www.federalregister.gov/documents/2026/09/02/2026-17928/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary) · `2026-17928`
- **Notice** [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](https://www.federalregister.gov/documents/2026/09/02/2026-17927/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary) · `2026-17927`

## 3 September 2026 — 1 document

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

- **Notice** [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](https://www.federalregister.gov/documents/2026/09/03/2026-18023/determination-that-phenaphen-with-codeine-no-3-acetaminophen-codeine-phosphate-oral-capsules-325) · `2026-18023`

## 4 September 2026 — 1 document

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

- **Notice** [Advancing Development of Botanical Drug Products; Request for Information](https://www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-development-of-botanical-drug-products-request-for-information) · `2026-18133`

## Ask an assistant instead

Everything on this page is also a tool call. Add `mcp.downstream.sh` as an MCP server — 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 and states what it is missing,
including which dates it has no record for.

---

Every document linked here is a work of the United States government and in the public domain.
The Federal Register's HTML and XML renderings are unofficial; the PDF on each item is the
official text, and that is the one to cite.

Counts are arithmetic over published fields, dates are printed as filed, and titles are verbatim.
Where we have nothing, this says nothing rather than estimating. The one-sentence agency summaries
are machine-written from those same fields and are labelled where they appear.

[Downstream](https://downstream.sh/) · [the essay](https://downstream.sh/essays/a-country-that-can-see.html) ·
[the daily issue](https://downstream.sh/daily/) · [MCP endpoint](https://mcp.downstream.sh)