FDA Law Blog: Critical Path Innovation Meetings: A New Opportunity to Discuss Drug Development Issues with FDA

By James E. Valentine*, Josephine M. Torrente & Frank J. Sasinowski –

On March 31, 2015, FDA’s Center for Drug Evaluation and Research (“CDER” or the “Center”) finalized its Guidance for Industry: Critical Path Innovation Meetings, establishing an enduring function of the Center to facilitate Critical Path Innovation Meetings (“CPIMs”).  The CPIM program is a tool for external stakeholders, including industry, academia, patient advocacy groups, or the government, to request a meeting to discuss a drug development methodology or technology with CDER outside of the context of review for any particular product or application.  more