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Tag: FDA

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OHRP and FDA Release Final Guidance on IRB Meeting Minutes

(PRIM&R) Public Responsibility in Medicine and Research

Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and…

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Cross Post: FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia

(PRIM&R) Public Responsibility in Medicine and Research

This post originally appeared on August 30 on the NIH Director’s Blog. To view other recent posts from the NIH…

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Research Ethics Roundup: Poor Enrollment of Seniors in Research, All of Us Research Program Pushes Transparency, FDA Announces 21st Century Cures Act Plans, EU Recommends Keeping Nonhuman Primate Research

(PRIM&R) Public Responsibility in Medicine and Research

This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive…

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Elisa Hurley
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From the Director: Importance of PRIM&R’s Membership Community

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R has long prided itself on its role as a convener of divergent opinions and viewpoints. One of the ways…

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Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency

(PRIM&R) Public Responsibility in Medicine and Research

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to…

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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.