FDA introduces a new program to expedite deployment of potential coronavirus treatments


The U.S. Food and Drug Administration  (FDA) announced a new program today that’s designed to foster close collaboration between public and private organizations in order to “bring coronavirus treatments to market as fast as possible,” according to U.S. Department of Health & Human Services Secretary Alex Azar in a press release. The program, dubbed the “Coronavirus Treatment Acceleration Program,” or CTAP, will see the FDA redeploy resources and personnel with an eye toward providing private companies, researchers and scientists with “regulatory advice, guidance and technical assistance as quickly as possible.”

In real-world terms, the FDA says that means it’s turning things around much more quickly, reviewing protocols for many freshly submitted clinical studies within 24 hours, and also turning around single-patient requests for expanded access to some therapies granted under compassionate or investigate use “generally within three hours.” The FDA is also looking at how it can build out streamlined protocols that can apply across use by different institutions and for different programs wherever possible to further limit processing time through templated strategies.