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Tag: FDA

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PRIM&R’s Comments on the FDA’s Proposed Rule, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations”

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or…

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Webinar Follow-Up: Responsible Conduct of Research

(PRIM&R) Public Responsibility in Medicine and Research

Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust…

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Webinar Follow-Up: Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape

(PRIM&R) Public Responsibility in Medicine and Research

Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated…

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Taking a Closer Look at the New Federal “Right to Try” Law

(PRIM&R) Public Responsibility in Medicine and Research

On May 30, 2018, the four-year Right to Try (RTT) movement culminated in a new federal law, with the stated…

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Elisa Hurley
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PRIM&R’s Comments on FDA’s Draft Guidance on Enrolling Pregnant Women in Clinical Trials

(PRIM&R) Public Responsibility in Medicine and Research

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical…

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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.