NEJM Interview: Dr. Joseph Ross on shifts in the FDA’s use of accelerated approval and associated challenges for clinicians and patients.
NEJM Interviews
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The Future of Accelerated Approval
The Food and Drug Omnibus Reform Act includes changes to the accelerated approval pathway. The biggest challenge is identifying patients who are willing to be randomized when it's already been approved by the FDA. streamlining the process for withdrawing drugs when postmarking studies are negative or delayed is really critical, he says.
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