SummaryJoin Avalere's Brenda Huneycutt, FDA Policy & Regulatory Strategy Practice, who will be moderating a panel with Avalere's Jenny Gaffney and other leading experts at the Biotech Showcase in San Francisco on Tuesday, January 14th at 8am, titled "FDA: where it's going and how it affects biotech."
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: