SACHRP Makes Recommendations on Draft FDA DCT and OHRP Limited IRB Review Guidances, Adds New Members

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SACHRP Makes Recommendations on Draft FDA DCT and OHRP Limited IRB Review Guidances, Adds New Members

J.W. Schomisch

July 31, 2023 at 11:45 AM EST

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) provided recommendations to both the FDA and the HHS Office for Human Research Protections (OHRP) on recent draft guidances dealing with FDA oversight of decentralized clinical trials (DCTs) and on OHRP’s guidance addressing the use of limited institutional review board (IRB) review, a new category of IR... Read More

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SACHRP Makes Recommendations on Draft FDA DCT and OHRP Limited IRB Review Guidances, Adds New Members

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