The U.S. Food and Drug Administration (FDA) recently issued “Diversity Action Plans to Improved Enrollment of Participants from Underrepresented Populations in Clinical Studies.”  This draft guidance “describes the form, content, and manner of diversity action plans, the applicable medical products, …

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The U.S. Department of Justice (DOJ) Drug Enforcement Administration (DEA) recently announced it is proposing a rule to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).  [See 21 U.S.C. § 812 Schedules of controlled …

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The National Academy of Medicine (NAM) Leadership Consortium conducts several “action collaboratives,” initiatives, and projects.  The 2-year NAM Health Care Artificial Intelligence Code of Conduct (AICC) Project is designed to provide “a guiding framework to ensure that AI algorithms and …

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The U.S. Department of Health & Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), just released Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent (Memo QSO-24-10-Hospitals).  The new guidance was announced in a 4/1/2024 …

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The National Association of Attorneys General (NAAG) recently sent a letter to Congressional leaders urging them “to engage in meaningful debate and reform of the current practices of pharmacy benefit managers (PBMs) and to take decisive action to reform the …

NAAG Urges Congressional Action on Pharmacy Benefit Managers Practices Read more »