3 ms·
> Expedited Programs for Serious Conditions: CDER has four broadly applicable programs to facilitate and expedite development and review of drugs for serious or
by duskwuff 3y ago
> Expedited Programs for Serious Conditions: CDER has four broadly applicable programs to facilitate and expedite development and review of drugs for serious or life-threatening conditions: Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval. In 2022, 24 of the 37 of CDER’s novel drug approvals (65%) used one or more of these expedited programs.
-- https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-...
I'm not certain if those are the same 24 drugs, but it seems likely -- in which case, this researcher has just empirically established that these fast-track programs exist. :)