Anonymous ID: b057f8 Dec. 14, 2021, 5:15 a.m. No.15190965   🗄️.is 🔗kun

>>15190948

 

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.

 

An eligible patient is a patient who has:

 

Been diagnosed with a life-threatening disease or condition

Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)

And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician

 

An eligible investigational drug is an investigational drug:

 

For which a Phase 1 clinical trial has been completed

That has not been approved or licensed by the FDA for any use

For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA

Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA

 

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try