Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” The FDA will continue to enhance this emergency program to bring safe and effective therapies to fight the coronavirus.
The FDA notes that there are now “10 therapeutics in active trials” and “another 15 therapeutic agents in planning stages.” The FDA notice outlines the steps the Agency is currently taking under the CTAP program, including support for the new therapies once the FDA is notified of requests from developers. Rapid deployment of the appropriate FDA staff, including high-level FDA decision makers, aids in providing close to immediate advice for the review of proposals, protocols, and development plans.
The Agency is using an all-hands-on-deck approach to address the pandemic and hopefully will be able to guide development and streamline the initial processes, emergency use authorizations for agents showing promise, and (ultimately) approval of beneficial therapeutic products in a reduced timeframe.
