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FDA releases draft guidance on ethical consideration for pediatric clinical investigations

(PRIM&R) Public Responsibility in Medicine and Research

On September 25, the US Food and Drug Administration (FDA) released a draft guidance, “Ethical Considerations for Clinical Investigations for…

Shows how research mice are intrinsically different than wild. Creating a problem for translatability in medical research.

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Do the 3Rs need to evolve for modern translational research with mice?

(PRIM&R) Public Responsibility in Medicine and Research

by Christopher S. Keator, Ph.D. Assistant Dean, Laboratory Animal Resources Founding Chair, WMed IACUC Assistant Professor, Department of Biomedical Sciences…

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The Benefits and Challenges of Decentralized Clinical Trials by Michele Russell-Einhorn and Julie Ozier

(PRIM&R) Public Responsibility in Medicine and Research

Many researchers and sponsors are continually looking for ways to optimize access to clinical trials for potential participants. That became…

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FDA proposes new rules to harmonize with Common Rule (Part II: protection of human subjects and IRBs) by Elisa A. Hurley, PRIM&R executive director

(PRIM&R) Public Responsibility in Medicine and Research

On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…

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FDA proposes new rule on Cooperative Research to harmonize with Common Rule by Elisa A. Hurley, PRIM&R executive director

(PRIM&R) Public Responsibility in Medicine and Research

On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) aimed at harmonizing…