A “new playbook” is needed to ensure consistent chemistry, manufacturing, and controls (CMC) reviews for gene therapy products, the lack of which is hindering the development of these products, asserted a top official at the US Food and Drug Administration . “Now is the time to get things right” asserted Peter Marks, director of the … Continue reading “FDA Official: New “Playbook” Needed for CMC Reviews of Gene Therapy Products”
Author: Joanne S. Eglovitch
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing and quality issues.