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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Early approvals may not be feasible for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
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.