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Who exactly needs to get approval from an institutional review board (IRB)?
IRB you kidding me?
Article 1 section 8 says the federal government has the power to (1) tax and spend, (2) regulate commerce, (3) control citizenship, (4) create post offices, (5) protect IP, (6) make treaties and (7) do war. In 1932, the United States government and Tuskegee University began studying 600 poor black sharecroppers in Macon Country Alabama, ⅔ of whom had latent syphilis. If you are a health care provider and you prescribe a marketed drug to treat a patient for an unlabeled indication (also referred to as off-label use), an IND is not required because this use is considered to be within the scope of medical practice and not a clinical investigation.
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