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What Is the Importance of PDUFA Dates in Drug Approval?

The FDA is tasked with reviewing new drug applications within a certain time frame, and PDUFA dates offer the agency deadlines by which to reach approvals. The Prescription Drug User Fee Act (PDUFA) was passed in 1992 and established PDUFA dates that, the law suggested, would ensure drug approval process remains efficient from a regulatory …

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