US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.
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US FDA’s Donald Ashley recaps past year’s precedent-setting responses to COVID-19 pandemic in interview, while outlining return to pre-COVID priorities and traditional inspection-based oversight.
Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it. One group went further, objecting to cGMP regulatory creep into the supply chain.
US FDA’s Donald Ashley recaps the past year’s precedent-setting responses to the COVID-19 pandemic in Pink Sheet interview, while outlining a return to pre-COVID priorities and traditional inspection-based oversight.