Development Of COVID-19 Therapies: FDA Pathways

DA is currently using 3 programs to expedite development of COVID-19-related therapies, with the goal of making new treatments available to patients in the US as quickly as possible. Note that the need and ability to utilize these programs will be dependent upon the status of the COVID-19 pandemic at the time your drug product is available and whether you are in a position to potentially engage with FDA in these programs.

At a high level, there are basically 3 (inter-related) programs that FDA has in place to make drug product available for COVID-19 patients in an expedited manner or under an “emergency” use status for products that are ready to initiate clinical studies, are already undergoing clinical development prior to approval of a new drug application, or are already approved in other indications.