FDA Issues Batch of Biologics Guidance Documents From July to October 2026
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The FDA has released a set of biologics guidance documents and drafts covering July through October 2026. The documents span several areas: blood donor eligibility, source plasma quarantine hold requirements, the electronic submission template for Premarket Approval Applications, and a questions-and-answers document on developing cellular and gene therapy products. Guidance issued in the same period also addresses cancer clinical trial eligibility criteria, specifically laboratory values, washout periods and concomitant medications, and performance status, with some of these issued as drafts rather than final guidance.
Written by a model from the reports · updated 3 hours ago
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- fda.govRecently Issued Biologics Guidance Documents
The FDA has listed biologics guidance documents and drafts issued from July to October 2026, covering blood donor eligibility, source plasma quarantine hold requirements, an electronic submission template for PMA applications, and FAQs on developing cellular and gene therapy products. Documents in the same period also address cancer clinical trial eligibility criteria on laboratory values, washout periods and concomitant medications, and performance status, some of them draft guidance.
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