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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The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
Stephen Hahn also said the expedited approval process could be even more efficient.