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# Critical Path Innovation Meeting MAPP
- URL: https://www.fdaweb.com/critical-path-innovation-meeting-mapp/
- Published: 2021-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:55:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149120

CDER has issued a Manual of Policies and Procedures (MAPP), *Critical Path Innovation Meetings*, to delineate the roles and responsibilities of CDER staff and outline the procedures to be followed for a critical path innovation meeting (CPIM). The MAPP defines a critical path innovation meeting as a nonbinding scientific dialog between FDA and investigators from industry, academia, patient advocacy groups, and/or government to explore novel ideas with the potential to augment drug development and advance regulatory science and policy.

The scope of such meetings includes biomarkers in the early phase of development that are not yet ready for the biomarker qualification program, clinical outcome assessments in the early phase of development that are not yet ready for the clinical outcome assessment qualification program, natural history study designs and implementation, emerging technologies or new uses of existing technologies, innovative conceptual approaches to clinical trial design and analysis, and patient-, clinician-, and observer-reported outcomes assessments.

The CPIM program is administered by the Office of Translational Sciences Immediate Office, Strategic Partnerships and Technology Transfer (SPT2) Program, the MAPP says.