Final Guidance: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act-2023/8/30

Final Guidance: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies-2023/8/30

Final Guidance: Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies-2023/8/25

Draft Guidance for Industry: Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndro

Final Guidance: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality-2023/7/26

Draft Guidance: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development-2023/7/11

Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements-2023/6/27

Draft Guidance: Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act-2023/6/27

Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations-2023/6/23

Draft Guidance: Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act-2023/6/21