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Pharmaceutical Industry Slams FDA’s Guidance On Drug Substance Post- Approval Changes; Say More Alignment With ICH Needed

Executive Summary

Like the fabled Rip Van Winkle, FDA guidance on post-approval changes for drug substances has awakened after a long nap to a changed world. Industry is urging FDA to revise its draft in a way that’s less prescriptive and more in line with the science- and risk-based approaches, outlined in ICH Q8, Q9 and Q12 guidelines, that have emerged in the years after the agency withdrew its BACPAC guidance.


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