New PDUFA VII Pilot Program for SMC Submission Packages
- Bill Benz
- Feb 22, 2023
- 1 min read
If you have ever supported Chemistry, Manufacturing, and Controls (CMC) submission packages for a product that has accelerated clinical development timelines, you know the challenges 😅! So the news that PDUFA VII has a pilot program for CBER- and CDER-regulated products to facilitate CMC readiness is welcome news indeed!!