US FDA Expects Updates On Investigational Gene Therapy CMC Improvements
Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
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What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed.