BIO Webinar: FDA Answers your Questions about the STAR Pilot Program

1:00 PM (EST), February 15, 2024
BIO Webinar: FDA Answers your Questions about the STAR Pilot Program
February 15, 2024
1:00 PM - 2:00 PM EST
Zoom

The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.

In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.

Speakers:

  • Cartier Esham, PhD, Chief Science Officer, BIO
  • Lashawn Schnupps, PharmD, Senior Regulatory Project Manager, FDA 
  • Kristy Lupejkis, Deputy Vice President and Chief of Staff, PhRMA