Recently Issued Guidance Documents
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- Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Guidance for Industry
CBER, August 2026 - Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry
CBER, August 2026 - Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry
CDER/CBER/OCP, August 2026 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Guidance for Industry
CDER/CBER, August 2026 - Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry
CDER/CBER, July 2026 - Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators
OCE/CDER/CBER, July 2026 - Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators
OCE/CDER/CBER, July 2026 - Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators
OCE/CDER/CBER, July 2026 - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry
CBER, June 2026 - Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
CDER/CBER, June 2026 - Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry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and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers; Draft Guidance for Industry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June 2026 - Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry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 - Conducting Remote Regulatory Assessments Questions and Answers; Guidance for Industry
OII/OCP/CBER/CDER/CDRH/CTP/CVM/HFP, 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