Veristat Resource Library

Leveraging FDA Expedited Programs To Accelerate Product Development


Presented by Veristat regulatory experts John Balser, Barbara Balser, Mara Holinger and Kevin Hennegan.

Veristat regulatory experts weigh in on how to use FDA expedited programs to improve your chances for success and possibly shorten timelines to approval.

View the webinar replay video to learn about the requirements, benefits, timing, and procedures for securing Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. We also discuss two newer programs: Regenerative Medicine Advanced Therapy (FDA guidance, Feb 2019) and Qualified Infectious Disease Program (FDA guidance, Jan 2018).