bio2018special programs

Regulatory Interactions and Opportunities at the Forefront of Innovative Manufacturing

4:00 PM–5:00 PM Jun 3, 2019 (US - Eastern)

106AB, Level 100


FDA has put into place a number of programs and meeting opportunities for Sponsors to discuss the use of different manufacturing technologies and techniques in an effort promote the adoption of innovative approaches and allow for early consultation with the Agency. These opportunities include meetings with the CDER Emerging Technology Team (ETT), and through CBER’s Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) among others.

This session will discuss FDA and Sponsor perspectives of the use of these programs, interactions between the two, and how the Agency and Sponsors are working together to promote the use of innovative technologies to better address manufacturing challenges to ensure high quality products. The session will include a Q&A and panel discussion

Session ID: 547915