The FDA is pulling out all the stops to accelerate COVID-19 therapies via a new program launched yesterday.
The agency has deployed staff specifically to reviewing COVID-19 therapies and is currently monitoring 10 in active trials and 15 others in planning stages as part of the Coronavirus Treatment Acceleration Program (CTAP).
The agency aims to review protocols within 24 hours of submission and to respond to single patient expanded access requests within three hours of submission.
“With a first wave of requests behind us, FDA will generally respond within a day,” to requests from developers and scientists seeking to develop or evaluate new drug and biologic therapies, the agency said. — Jordan Williams