FDA’s Expedited IND Pilot Comes Into Focus By Sarah Wicks —

https://www.thefdalawblog.com/2026/08/fdas-expedited-ind-pilot-comes-into-focus/?utm_source=rss&utm_medium=rss&utm_campaign=fdas-expedited-ind-pilot-comes-into-focus FDA has made no secret of its desire to bring more early-stage clinical development back to the United States. As part of HHS’s Operation TrialBlazer, FDA recently proposed an Expedited Investigational New Drug (“IND”) Pilot Program intended to shorten the path to first-in-human (“FIH”) trials. Following a June Request for Information (“RFI”), CBER Acting Director Karim Mikhail provided additional detail in an FDA Voices post, and FDA held an August 6 webinar to explain its current thinking.