from an article I just read: The compassionate
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Posted On: 09/23/2021 8:25:57 AM
from an article I just read:
The compassionate use process goes like this: The patient’s physician identifies a potentially beneficial drug in development and requests it from the entity developing it. If that company, also known as the sponsor, agrees to provide the drug — and there is nothing in any regulation requiring any sponsor to provide compassionate use — then the request goes to the FDA for review. If the FDA allows the request to proceed, an institutional review board, a body charged with the protection of human research participants, must sign off on the protocol proposed for delivering the intervention and the informed consent form the patient would need to complete before beginning it.
The compassionate use process goes like this: The patient’s physician identifies a potentially beneficial drug in development and requests it from the entity developing it. If that company, also known as the sponsor, agrees to provide the drug — and there is nothing in any regulation requiring any sponsor to provide compassionate use — then the request goes to the FDA for review. If the FDA allows the request to proceed, an institutional review board, a body charged with the protection of human research participants, must sign off on the protocol proposed for delivering the intervention and the informed consent form the patient would need to complete before beginning it.
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