STAT+: FDA takes applications for new program to shorten drug approval times

The pilot aims to help companies move more quickly to testing their products in humans Adobe Margaret is a Washington correspondent covering the Food and Drug Administration and other federal health agencies. Reach her on Signal at margaretmanto.61. WASHINGTON — The Food and Drug Administration is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday. The pilot was first announced in June as part of Operation TrialBlazer, the Department of Health and Human Services initiative that pledged to shorten the FDA’s drug approval timelines and help the U.S. compete with the rapidly accelerating biotechnology industries in countries like China and Australia. “Too often, the U.S. pathway can be measured in years, while other countries’ pathways are measured in months,” the department wrote in the TrialBlazer roadmap. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe Margaret is a Washington correspondent covering the Food and Drug Administration and other federal health agencies. Reach her on Signal at margaretmanto.61.