FDA and EMA re-launch parallel advice pilot for complex generics

BY AMANDA CONTI

The path to market for complex generics and hybrid products is complicated, and regulatory harmonization efforts in this space are lacking. FDA and EMA launched the Parallel Scientific Advice (PSA) Pilot Program for Complex Generic/Hybrid Products in September 2021. With just two takers going through the program in over two years, the FDA is again encouraging participation and addressing industry concerns.

Fill out the form to read the full article.

Required *

Copy link
Powered by Social Snap