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Latest From Manufacturing
The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.
US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.
Serialization Update: Industry Warns Of “Significant Disruptions” If FDA Bars Use Of GSI Global Numbers Under DSCSA
Pharmaceutical Industry Slams FDA’s Guidance On Drug Substance Post- Approval Changes; Say More Alignment With ICH Needed
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.
Moving more manufacturing to the US could help increase supply chain reliability, which could prevent or blunt shortages, an industry representative argues.
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