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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On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.…
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In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning (AI/ML) protocols were quick to give not-human subject research…
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Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed…
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