Newsletter

CMC Insights Newsletter

CMC Insights is Verta’s monthly newsletter on CMC and regulatory developments.

All issues

Friday, September 4, 2026

FDA Pushes Earlier CMC Readiness

Four July and August developments from FDA and EMA point the same way: CMC can no longer be a workstream that catches up to clinical development later.

Verta Life Sciences

Friday, July 31, 2026

FDA’s Three-Week Sprint to Modernize U.S. Drug Manufacturing

FDA and HHS moved on four fronts in three weeks: Operation TrialBlazer, a proposed registration rule, the PreCheck pilot, and rewritten inspection programs.

Verta Life Sciences