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New PDUFA VII Pilot Program for SMC Submission Packages

If you have ever supported Chemistry, Manufacturing, and Controls (CMC) submission packages for a product that has accelerated clinical development timelines, you know the challenges ๐Ÿ˜…! So the news that PDUFA VII has a pilot program for CBER- and CDER-regulated products to facilitate CMC readiness is welcome news indeed!!


https://www.federalregister.gov/documents/2022/10/31/2022-23575/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement

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