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FDA Approval Path

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

 

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

 

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

 

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

 

Charging for Investigational Products | FDA Click Here

 

Here is the reference at FDA.gov that says you can charge for related treatments. Click Here

 

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

 

FDA Right to Try Path