REMS

News & Analysis as of

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which summarizes stakeholder engagements completed in fiscal year...more

Healthcare Tops the Agenda of U.S. Antitrust Enforcers

Agencies promise close scrutiny of hospital mergers, reverse payment settlements, and REMS abuses. During a roundtable discussion featuring federal and state enforcers at the American Bar Association Section of...more

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