On May 11, 2020, the U.S. Food and Drug Administration (FDA) announced actions to accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.

In response to the novel coronavirus (COVID-19), FDA created the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biologics (other than vaccines) for COVID-19 therapeutics. CTAP enabled CDER and CBER to leverage cross-agency scientific resources and expertise for COVID-19 therapeutic development and review and provide extensive guidance and information to companies, researchers, patients, and consumers. CTAP helped FDA achieve numerous critical milestones in the COVID-19 response. In the three years since CTAP’s beginning, there have been several hundred development programs and clinical trials reviewed by FDA for COVID-19 therapeutics, and numerous available treatments that were authorized for emergency use or approved by FDA for use in COVID-19.

The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP  remains vital to the expedited development of COVID-19 therapeutics, particularly for programs that are intended to address an unmet medical need. Using available regulatory mechanisms, CTAP strives to facilitate access to safe, effective, and high-quality treatments for COVID-19. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19.