Technical
This article discusses the impact on Chemistry, Manufacturing and Control (CMC) part of a development project when a project is assigned Breakthrough Therapy (BT) status as given in Food and Drug Administration Safety and Innovation Act (FDASIA)1 and FDA...
- 1Food and Drug Administration Safety and Innovation Act (FDASIA), (Pub. L. 112-144), 9 July 2012, www.fda.gov.