Dr. J's positioning via Compassionate Use:
No, compassionate use is not a direct path to FDA drug approval; rather, it is an FDA-regulated pathway for patients with serious diseases to access investigational drugs when *** no COMPRABLE alternatives are available ***
It is a distinct process from the traditional clinical trial and approval process, though a successful compassionate use program can be used by the drug's manufacturer to support their FORMAL FDA submission.
& these bulletpoints...
Eligibility:
Patients must have a serious condition with no other satisfactory treatment options available outside of a clinical trial.
Process:
Requires approval from the FDA, the drug manufacturer, and an Institutional Review Board (IRB).
Outcome:
While not a direct approval, the data gathered from a compassionate use program can contribute to the manufacturer's FINAL submission for FDA approval.
---
So, if/when our CU is approved...supports key aspects.
No, compassionate use is not a direct path to FDA drug approval; rather, it is an FDA-regulated pathway for patients with serious diseases to access investigational drugs when *** no COMPRABLE alternatives are available ***
It is a distinct process from the traditional clinical trial and approval process, though a successful compassionate use program can be used by the drug's manufacturer to support their FORMAL FDA submission.
& these bulletpoints...
Eligibility:
Patients must have a serious condition with no other satisfactory treatment options available outside of a clinical trial.
Process:
Requires approval from the FDA, the drug manufacturer, and an Institutional Review Board (IRB).
Outcome:
While not a direct approval, the data gathered from a compassionate use program can contribute to the manufacturer's FINAL submission for FDA approval.
---
So, if/when our CU is approved...supports key aspects.
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