Oncology Center of Excellence Director Richard Pazdur believes the US Food and Drug Administration needs to do a better job explaining to the public why it might not automatically seek withdrawal of an accelerated approval drug when a confirmatory trial fails.
Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail
Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project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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