Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use-2025/11/17

How to Prepare a Pre-Request for Designation (Pre-RFD)-2025/11/6

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies-2025/10/29

Menstrual Products – Performance Testing and Labeling Recommendations-2025/10/28

Quality Management System Information for Certain Premarket Submission Reviews Draft Guidance for Industry and Food and Drug Administration Staff-2025/10/27

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments-2025/10/22

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers-2025/10/22

Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias-2025/10/16

CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication-2025/10/14

E20 Adaptive Designs for Clinical Trials-2025/9/30