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

 
• By Joanne S. Eglovitch

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.

FDA entrance sign 2016

Even as drug makers applauded the reemergence of FDA guidance on post-approval changes for drug substances, they criticized the prescriptive nature of the guidance document the agency drafted.

The draft guidance is out of keeping with international drug quality principles that have emerged since the agency withdrew the...

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