Recently Issued Guidance Documents
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- Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
CDER/CBER, June 2026 - Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, June 2026 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers; Draft Guidance for Industry
CDER/CBER, June 2026 - Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
CBER, June 2026 - Postapproval Pregnancy Safety Studies; Guidance for Industry
CDER/CBER, May 2026 - Submitting Continuous Glucose Monitoring Data in Clinical Trials; Guidance for Industry
CDER/CBER, May 2026 - Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance for Industry
CBER, May 2026 - Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry
CDER/CBER/OCLiP/OCE, April 2026 - Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
CBER, April 2026 - Bioanalytical Method Validation for Biomarkers; Guidance for Industry
CDER/CBER, April 2026 - Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 2026 - Pyrogen and Endotoxins Testing: Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/CVM/ORA, March 2026 - Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry
CDER/CBER, March 2026 - Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection; Draft Guidance for Industry
CDER/CBER/CVM/OII, March 2026