Newsletter
CMC Insights is Verta’s monthly newsletter on CMC and regulatory developments.
September brought several important CMC and manufacturing developments that point to a broader shift in FDA’s approach to drug development and regulatory review.
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.
FDA and HHS moved on four fronts in three weeks: Operation TrialBlazer, a proposed registration rule, the PreCheck pilot, and rewritten inspection programs.