March 30, 2020

4 CMC Topics to Discuss During Milestone Meetings

e FDA recognizes that CMC-specific discussions, during Pre-IND meetings, are typically unnecessary when projects are “straightforward.” However, unlike more traditional 505(b)(2) products, certain new chemical entities (NCE’s) and biologics are anything but straightforward. These novelties can create unique manufacturing roadblocks that impede the path to clinical development.