The FDA issued draft guidance for industry, titled “Use of Data Monitoring Committees in Clinical Trials,” to assist sponsors of…
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FDA and the Office for Human Research Protections (OHRP) issued a 16-page draft guidance, entitled “Key Information and Facilitating Understanding…
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The FDA issued guidance in August 2023 to provide more clarity to IRBs, clinical investigators, and sponsors in complying with FDA’s informed…
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On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…
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On May 3, 2022, PRIM&R hosted a webinar, Un-Common Rules: Navigating FDA-Regulated Research and the IRB. During the webinar, Belinda…
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