Handbooks | FDA

Guide to Good Clinical Practice

Quick Links

RECENT UPDATES

Nov 4, 2025
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies (Draft Guidance — October 2025) (draft guidance added).
Oct 28, 2025
503 - Expanded Access and Charging for Investigational Products - additional information from FDA October 2025 guidance
Oct 24, 2025
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Final Guidance – October 2025) (final guidance added)
Oct 24, 2025
Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (Final Guidance - October 2025) (final guidance added)
Oct 21, 2025
Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias (Final Guidance — October 2025) (final guidance added).

Copyright © Thompson FDA, a division of CBIS. All rights reserved.