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Applications Final Guidance

Bass, Berry & Sims PLC

OHRP Finalizes Guidance on Elimination of IRB Review of Research Applications and Proposals

Bass, Berry & Sims PLC on

Today, the Office for Human Research Protections (OHRP) will publish a notice in the Federal Register that its “Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018...more

Kelley Drye & Warren LLP

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

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