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  This draft guidance “describes the form, content, and manner of diversity action plans, the applicable medical products, …

FDA Draft Guidance on Improving Underrepresented Population Enrollment in Clinical Studies Read more »

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 …

DEA Proposes Transferring Marijuana to Schedule III Read more »

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 …

After Concerns over Intimate Exams HHS Clarifies Guidelines for Informed Consent Read more »

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 »

Ohio Governor Mike DeWine recently issued Executive Order 2024-01D effectively banning gender transition surgery in Ohio for persons under the age of 18.  The Executive Order allowed the immediate adoption of new Ohio Administrative Code (OAC) Rules 3701-59-06 and 3701-83-60 …

Ohio Governor Bans Gender Transition Surgery for Minors Read more »