Darren Incorvaia in Fierce Biotech:
After teasing a new initiative to speed up early-stage clinical trials over the summer, the FDA today opened a pilot program for an expedited investigational new drug (IND) application process that the agency hopes will put U.S. phase 1 trials on par with those in China and Australia. The finalized pilot program will pair drug sponsors with selected “qualified research institutions” or QRIs, which can include contract research organizations, academic medical centers, regulatory advisors and other related entities.
QRIs and sponsors accepted into the program will be paired up, with the intention of then submitting an IND on a faster, rolling basis. FDA staff will review applications and choose around eight or 10 pairs for the pilot, which is accepting submissions until Oct. 30.
More here.
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