Recently Issued Biologics Guidance Documents
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- Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry
CBER, October 2026 - Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy
CBER, October 2026 - Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
CBER, October 2026 - Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry
CBER, September 2026 - Electronic Submission Template for Premarket Approval Applications (PMA); Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2026 - 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CBER, August 2026 - Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry
CBER, August 2026 - Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry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and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry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