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Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.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