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Does an IRB need to register with FDA before approving studies?

April 26, 2017approving fda IRB REGISTER

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Does an IRB need to register with FDA before approving studies?

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Currently, FDA does not require IRB registration. The form FDA-1572 “Statement of Investigator” for a study conducted under an IND requires the name and address of the IRB that will be responsible for review of the study. IRBs that approve studies of FDA regulated products must be established and operated in compliance with 21 CFR part 56.