FDA Drugs· FDA·· 4 hours agoScore52
Recently Issued Biologics Guidance Documents
In brief
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criteria on laboratory values, washout periods and concomitant medications, and performance status, some of them draft guidance.
Source: FDA Drugs · fda.gov