Scientists around the world are working around the clock to find and test potential COVID-19 treatments, and get them to the market as quickly as possible. A promising option is to repurpose existing treatments for use in a different therapeutic area (such as COVID-19), via the 505(b)(2) process.

In this recorded discussion, Altasciences’ experts offer insight into how to navigate through the different challenges of the (re)approval process, including:

• The steps taken by the Regulatory Agencies when analyzing such submissions

• The clinical studies required and reasoning for further clinical testing of previously approved drugs

• The estimated timeline for approval of a 505(b)(2) submission

• The process for inclusion of non-U.S. trial data to support a 505(b)(2) submission

Want to watch the video? https://www.youtube.com/watch?v=Rxal6Khm7dM