💊FDA Workshop on CMC Development
Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop; Request for Comments
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual-only public workshop entitled "Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program." This workshop fulfills a commitment in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII) to hold a public meeting to discuss best practices and lessons learned from this pilot program. Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will feature sponsors and FDA experience under this pilot program and will solicit input on future directions for FDA policy and programs to facilitate expedited CMC development of products under an investigational new drug application (IND), where indicated based upon the anticipated clinical benefits.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content involves a public workshop aimed at gathering industry feedback on CMC development practices under expedited FDA programs. The outcomes may influence future regulatory requirements and business practices for drug manufacturers, affecting compliance strategies and development timelines.