Breakthrough Therapies: Maintain The Statistical Rigor, Industry Says
Janssen statistician says FDA should ensure breakthrough sponsors follow the rules just like traditional applicants, although agency statistician experience with designees has been limited.
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Janet Woodcock says agency still cannot detail specific criteria for the popular incentive, but data on breakthrough requests show common characteristics.
Although drugs on the FDASIA-created expedited pathway may promise more than they can deliver, it will be difficult to reduce demand for such treatments awarded the designation, Boston researchers predict in a NEJM piece.
Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.