Inspection Questions Delay CBER’s Embrace Of Real-Time Oncology Review
The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.
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Most US agencies can expect relatively friendly oversight from a Democratic Congress. The US FDA might be one exception, as a recent House hearing on foreign inspections shows.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.
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.