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Gu idance for Industry IRB Rev ie w of StandA lone HIPAA Au thorizations Under FDA Regu lations FINAL GUIDANCE This guidance is being distributed for immediate implementation

FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10115g3 without seeking prior comment because the agency has determined that prior public participation would not be feasible or appropriate FDA made this determinat

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Gu idance for Industry IRB Rev ie w of StandA lone HIPAA Au thorizations Under FDA Regu lations FINAL GUIDANCE This guidance is being distributed for immediate implementation






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