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Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail

Executive Summary

Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.

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