ARTICLE | Regulation
FDA revamps NDA process to get top problems to sponsors faster
FDA wants to give sponsors an early heads-up for NDAs that might be heading for trouble
August 2, 2019 9:01 PM UTC
FDA has two primary goals in its overhaul of the NDA process. The first is to find the show-stopping issues sooner and put that information in sponsor’s hands. The second is to create more time to discuss labeling and post-marketing requirements with them.
How it does that is via an internal reorganization of the process and a new review template. ...