Compassionate use

[nebrhahe53]

Does anyone have experience writing a compassionate use letter for a drug in clinical trials? Who do we write to the company, the FDA etc

 

[Nikki J]

I don't but this NEALS webinar talks about it a bit.
https://vimeo.com/116354668

 

[lgelb]

Your doc would write the FDA. If the FDA were inclined to approve the request, they would ask the mfr, who would also have to approve (and have or make available the necessary supply). Your insurance likely wouldn't pay for it ("investigational") so you would have to.