FDA Answers your Questions about the STAR Pilot Program

FDA Answers Questions About the STAR Pilot Program video tile
FDA Answers your Questions about the STAR Pilot Program
February 15, 2024

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.

FDA Answers Your Questions About the STAR Pilot Program presentation deck
Moderators & Speakers
Cartier Esham
Cartier Esham, PhD
SENIOR ADVISOR
Biotechnology Innovation Organization
LaShawn Schnupp
LaShawn Schnupp, PharmD
Senior Regulatory Project Manager
U.S. Food and Drug Administration
Kristy Lupejkis headshot
Kristy Lupejkis
Deputy Vice President and Chief of Staff
PhRMA