FDA’s CTAP to Expedite COVID-19 Countermeasures

The U.S. FDA has established a new program across public, academic and private sectors to combat the COVID-19 pandemic. Designed to expedite the development of potentially safe and effective life-saving treatments, the program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, as well as support research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

"The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump's all-of-America approach is making progress and providing new hope in our fight against the coronavirus."   

"The problem is that the standard drug approval process is cautious by nature, designed to rule out major safety risks first before experimental drugs are used in trials large enough to prove a clinical benefit. With CTAP, the FDA is trying to streamline as many aspects of that process as it can. Gilead Sciences' experimental antiviral remdesivir was one of the first to be sped into coronavirus patients, while the anti-inflammatory drugs Actemra from Roche and Kevzara from Sanofi have been authorized for experimental use in some coronavirus patients with respiratory distress."

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