FDA Announces the Creation of CTAP—Coronavirus Treatment Acceleration Program—to Assist Drug Developers and Evaluators

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The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program (CTAP). Specifically, FDA has created a dedicated team to quickly address any inquiries or requests regarding the development of COVID-19 therapies and treatments. Those seeking to develop or evaluate new drug and biological therapies should take advantage of CTAP to more quickly receive FDA guidance and approval.

The goal of CTAP is to move treatments to patients as quickly as possible while also ensuring the efficacy of such treatments. To meet this goal, FDA has redeployed medical and regulatory staff to review teams dedicated to COVID-19 therapies, streamlined the process for requesting technical guidance and support related to drug development, and provided resources to the healthcare industry about how to submit emergency requests to use investigational products for patients with COVID-19 infections. 

While FDA has not provided a complete outline of CTAP, it has provided informative examples of how the program has been used thus far and how drug developers and testers can take advantage of the program moving forward. Primarily, FDA is triaging requests and inquiries to properly connect FDA staff with requestors, providing quick and interactive input to development plans, providing accelerated review of protocols, and completing reviews of single patient expanded access requests, i.e., requests to use investigational drugs or treatments for a particular individual. FDA is also assisting applicants and other regulatory agencies to expedite quality assessments for these products as well as to transfer manufacturing to alternative sites where applicable.

FDA encourages developers and evaluators of COVID-19 therapies to communicate with FDA early and often to ensure that development of drugs and other therapies to treat COVID-19 are properly implemented and meet efficacy requirements of FDA. Indeed, FDA expects to respond to all requests for development and evaluation of therapies within a day. Responses for protocol review also are provided “in many cases” within 24 hours of submission of the request. For review of single patient expanded access requests, FDA reviews such requests around the clock and generally completes its review within 3 hours.   

The COVID-19 crisis is a fluid situation generating a multitude of issues on a daily basis. Seyfarth regulatory attorneys are closely monitoring the situation around the clock. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our COVID-19 Resource Center for more information.