Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations-2023/6/23

Draft Guidance: Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act-2023/6/21

Draft Guidance: E6(R3) GOOD CLINICAL PRACTICE (GCP)-2023/6/6

Final Guidance: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions-2023/6/5

Final Guidance: Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals-2023/6/2

Guidance for Industry - Migraine: Developing Drugs for Preventive Treatment Drug Trials Snapshot: PYRUKYND-2023/6/1

Final Guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products-2023/5/25

Draft Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information-2023/5/24

Final Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers-2023/5/24

Draft Guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act-2023/5/17