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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FDA Breakthrough Designation Standards Revealed (Kind Of)
Janet Woodcock says agency still cannot detail specific criteria for the popular incentive, but data on breakthrough requests show common characteristics.
“Breakthrough Therapies” Deserve Skepticism, Researchers Say
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.
FDA Strains Under New NDA Review Model; Will Industry Want To Retain It?
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.