Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When
Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
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Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
FDA seeks expert comments during an upcoming public meeting on strategies to facilitate various centers combining and sharing data.
Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.