An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program | FDA

An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program | FDA

A Behind the Scenes Look at How FDA is Working to Facilitate COVID-19 Treatments

When the FDA learned of the novel coronavirus (COVID-19) and its potentially devastating effects, we acted swiftly to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease. To meet this urgent need, the FDA created the Coronavirus Treatment Acceleration Program (CTAP) to enable the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to leverage cross-agency scientific resources and expertise to bear on COVID-19 therapeutic development and review. We’re excited to say that there are now more than 510 drug development programs in planning stages, and as of today, the agency has reviewed more than 230 trials of potential therapies for COVID-19. (July 14, 2020)

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Related links: Coronavirus Treatment Acceleration Program (CTAP) - On July 14, 2020, FDA updated the CTAP webpage and posted key materials to provide information about CTAP’s purpose, strategy and operations. Specifically, this update included posting a dashboard showing crucial statistics related to the development of potential COVID-19 therapeutics. New web page: Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19 (July 14, 2020) Coronavirus (COVID-19) | Drugs Coronavirus (COVID-19) | CBER-Regulated Biologics