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FDA Approval Path

Find essential FDA guidelines, forms, and resources to navigate the approval process with confidence.

The Future of Regeneration

Navigating the FDA Approval Path

Part 1. FDA Chief Project Manager Monica Hughes provides an introduction to Expanded Access for investigational medical products. Click Here

Part 2. Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions. Click Here

Part 3. Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions. Click Here

Part 4. Provides instructions on completing Form FDA 3926, a one-page form, front and back for initial submissions. Click Here

Individual Patient Expanded Access Investigational New Drug Application (IND) Download, Print and Fill out

FDA Right to Try Path

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