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US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

 
• By Bowman Cox

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

medicine stocks
fda recommends more planning to keep shelves stocked • Source: Shutterstock

The US FDA has drafted guidance on congressionally mandated supply chain “redundancy risk management plans” that says who the agency expects to develop the plans, what it expects the plans to contain, what drug products they should cover, and how they should be developed.

The FDA recommends more stakeholders develop the plans than the March 2020 Coronavirus Aid, Relief and Economic Security Act requires, and that they develop the plans for more drug products than the

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