Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials
Oncology Center of Excellence Director Richard Pazdur also says that he will not grant an accelerated approval if the confirmatory trial is not underway, even if the product shows safety and efficacy.
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There is a greater commitment among larger, well-capitalized oncology companies to complete confirmatory trials, Oncology Center of Excellence Director Richard Pazdur says; smaller company approach of first getting accelerated approval and then using commercial proceeds to capitalize confirmatory trial is ‘unacceptable.’
Sarepta says another public meeting is not necessary to expand the label for its DMD gene therapy, but the missed primary endpoint may require input from experts outside the FDA, and the situation renews the spotlight on CBER Director Peter Marks and his initial approval decision.
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.