Critical Path Initiative
Transforming the way FDA-regulated products are developed, evaluated, and manufactured
Highlights
- Clinical Path Innovation Meetings (CPIM) for drug developers seeking CDER general advice on a proposed methodology or technology
- Examples of publications from the Center of Drug Evaluation and Research Critical Path research funding program (PDF - 146KB)
- FDA's 2012 Clinical Investigator Training Course Videos
- FDA's Guidance Webinar Series NEW!
- Video, slides, transcript, and audience questions from Oct. 24 Guidance Webinar
"Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring" - Slide Presentation on FDA's Critical Path Draft Guidance on Electronic Source Documentation in Clinical Investigations
- Guidance for Industry Electronic Source Data in Clinical Investigations (PDF - 190KB)
About Critical Path
The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way FDA-regulated medical products are developed, evaluated, and manufactured. ... More