FDA Answers Questions about the Split Real-Time Application Review (STAR) Pilot Program hosted by BIO

Description

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:
– Opening Remarks: Cartier Esham, PhD, Chief Science Officer, BIO
– LaShawn Schnupp, PharmD, Senior Regulatory Project Manager, FDA
– Closing Remarks: Kristy Lupejkis, Deputy Vice President and Chief of Staff, PhRMA

Please submit your questions for our speaker in advance using the "Questions & Comments" box at the bottom of this registration form.