What Makes a "Breakthrough" Therapy? FDA Says More Details Are Coming
This article was originally published in RPM Report
FDA’s Janet Woodcock believes the agency will be able to provide more concrete parameters around what constitutes a “Breakthrough” product in its final guidance document on the agency’s expedited programs. Maybe that will help lower the rate of denials.
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FDA has granted more than two dozen “Breakthrough Therapy” designations. Not everyone is sure that’s a great thing. Payors, in particular, are getting “nervous” about what hyperfast development of hyper-expensive therapies will mean.
FDA denied 10 requests for breakthrough therapy within a four-week period. The reasons behind the wave of rejections are unclear, but may be inherent to the rollout of the program.
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.