Draft Guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations-2023/5/17

Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices-2023/5/2

Draft Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment-2023/4/19

Draft Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry-2023/4/12

Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs-2023/4/12

Draft Guidance: Over-the-Counter Monograph Order Requests: Format and Content-2023/4/12

Draft Guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making-2023/4/5

Draft Guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act-2023/4/5

Identification of Medicinal Products — Implementation and Use(Final)-2023/3/31

Pharmacogenomic Data Submissions(Draft)-2023/03/17