IRB board and compassionate exemption

[Guest guest]

Hi,

I am trying to get a drug for my wife by means of a

compassionate exemption. I have heard 2 opinions. One is

that it is more difficult to get the exemption when the

oncologist is part of a large teaching hospital and the

hospital requires IRB approval to obtain and dispense the

drug.. The other theory I heard was that you can go through

a local oncologist if the drug manufacturer doesn't require

a IRB board approval. Does anyone have any info on this?

Thanks,

Hal

[Guest guest]

Drugs that are not approved by the FDA always require IRB

approval. Some IRBs are institutional, while others are

more national and oversee physicians at different

institutions and in private practice.

Rick Furman

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