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Home » FDA Issues Update on PDUFA VII Reauthorization Discussions
FDA Issues Update on PDUFA VII Reauthorization Discussions
The FDA has released more meeting minutes from its talks with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA), noting that there is interest in seeing the agency commit to expanding its use of real-world data in drug reviews, its capabilities for cell and gene therapy products, and other changes.