On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…
Read MoreOn May 3, 2022, PRIM&R hosted a webinar, Un-Common Rules: Navigating FDA-Regulated Research and the IRB. During the webinar, Belinda…
Read MoreOn April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.…
Read MoreIn the not-so-distant past, IRBs reviewing artificial intelligence and machine learning (AI/ML) protocols were quick to give not-human subject research…
Read MoreHave you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed…
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