Gene Therapy: Industry Seeks Greater Clarity In Final FDA CMC Guidance On INDs
Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies. Questions center on a scope that ranges from CTD to GMP, from in vivo to ex vivo, and from IND to BLA.
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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.
FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”