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Tag: FDA

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PRIM&R On How FDA Can Improve its Clinical Trial Diversity Guidance

(PRIM&R) Public Responsibility in Medicine and Research

On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials.…

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Establishing a Clear Pathway for IRB Review of Artificial Intelligence/Machine Learning in AI Human Subject Research That Involves Software as a Medical Device

(PRIM&R) Public Responsibility in Medicine and Research

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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A stack of books titled Rules and Regulations
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No fear, just proper preparation–IRB Professionals and the FDA

(PRIM&R) Public Responsibility in Medicine and Research

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed…

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Califf giving keynote address at 2017 PRIMR conference
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Califf Confirmed As FDA Commissioner—Watch His AER17 Keynote

(PRIM&R) Public Responsibility in Medicine and Research

On Tuesday, February 15, Robert Califf, PhD, was confirmed by the US Senate to the position of commissioner of the…

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Hands typing on a laptop
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Research Ethics Roundup: surprise billing in clinical trials, Swiss referendum on animal testing, and more

(PRIM&R) Public Responsibility in Medicine and Research

This month's Research Ethics Roundup covers two major movements in the Biden administration's science personnel, a new and potentially problematic…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.