Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review
US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.
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Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.
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.