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BridgeBio's Chief Regulatory Affairs Officer Adora Ndu on PDUFA VII Reauthorization

Author
Erin Harris
Published
Thu 13 Oct 2022
Episode Link
None

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On the heels of Congress' reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act, BridgeBio's Chief Regulatory Affairs Officer, Adora Ndu, explains the Commitment Letter, the programs that may be rolled out under PDUFA VII, why right-sizing CBER will help the cell and gene sector going forward as well as how sponsor companies can prepare for 2023 from a regulatory perspective.

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