Brenda’s panel will focus on FDA’s four programs intended to speed up drug sponsors’ drug development and regulatory review processes for therapies treating serious conditions. The programs, called “expedited programs,” include: fast track, priority review, accelerated approval, and breakthrough therapy designation. Brenda’s panel will explore how these programs are changing biotech, what the benefits of these programs are, how they increase a product’s value, and how to apply for these programs.
Hope to see everyone in January.
Listen to a preview of the session here: