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Originally posted by Phaedrus:
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Inadvertently left out the best extract of the lot, as I see it: Expedited Programs FDA encourages the development of non-opioid analgesic products and novel study designs. Non-opioid analgesic development programs designed to replace or reduce the use of opioid analgesics may be eligible for one or more of FDA’s expedited review programs, as applicable. FDA encourages early discussion of products that could eliminate or reduce opioid analgesic use and may be suitable for expedited reviews. The applicable expedited programs include fast track, breakthrough therapy, priority review, and accelerated approval. Although each program differs, they all offer some form of expedited review and guidance for sponsors for drug development programs.FDA has not had experience with an analgesic approval based on a surrogate or intermediate endpoint that is reasonably likely to predict clinical benefit , as would be consistent with accelerated approval. Given that pain intensity is a subjective experience that can only be directly reported by the patient, it is difficult to envision how surrogate or intermediate endpoints could be used to predict analgesic effect. However, consistent with applicable statutory criteria, FDA will consider a non-opioid analgesic’s abuse or misuse potential and its risk profile relative to available opioid analgesics to determine if the application qualifies for fast track or breakthrough designation during development, or for priority review upon receipt of the marketing application.
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you’re living up to you name @Phaedrus - simply brilliant posts!
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