Archived documents

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

FDAOther

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry

DEANotice

2026-08586

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs

FDANotice

Pediatric Dosing Information for Over-the-Counter Human Drugs; Intent and Request for Information

DEAProposed Rule

Schedules of Controlled Substances: Removal of Exemption Status for Inactive Butalbital Products

DEANotice

2026-08585

DEANotice

2026-10089

DEANotice

2026-13164

FDANotice

Pediatric Dosing with Over-the-Counter Drug Products; Summary Information Document for Advisory Committee Meeting; Availability; Establishment of a Public Docket and Request for Comments

FDANotice

Determination That SERZONE (Nefazodone Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", also download published version into the folder.

FDANotice

Determination That DIAZEPAM Injection United States Pharmacopeia (5 Milligrams/Milliliter in a 1- Milliliter Container) Was not Withdrawn From Sale for Reasons of Safety or Effectiveness