FDA Launches Program to Expedite Development of COVID-19 Treatments

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On March 31, 2020, the U.S. Food and Drug Administration (FDA) announced the launch of the Coronavirus Treatment Acceleration Program (CTAP). The program was created to provide promising in-development Coronavirus Disease 2019 (COVID-19) treatments to patients while using preliminary data to evaluate whether the treatments are safe and effective. There are currently 10 COVID-19 therapeutic agents in clinical trials and 15 more in the planning stage of development.

The FDA’s website for CTAP lists examples of actions that the agency has taken to accelerate the development of COVID-19 treatments. These efforts have included rapid evaluation of new drug and biologic therapies, providing input on development plans, reviewing many developer protocols within 24 hours of submission, generally reviewing single patient expanded access requests within three hours, and expediting quality assessments. Regarding the program’s future work, the FDA has committed to continue expanding the program while keeping the public updated about promising candidates to treat COVID-19, including therapeutic agents in the clinical and pre-clinical stages of development.

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