Business · 14/11/2022Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Viral Safety Evaluation of Biotechnology Products
Summary
The FDA has made available a draft guidance document outlining risk-based principles and mitigation strategies for ensuring the viral safety of biotechnology products derived from human or animal cell lines, updating a 1998 ICH guidance to reflect recent scientific advancements and regulatory expectations.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →