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HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Navigating Executive Orders: Insights and What Lies Ahead

On January 20, 2025, a new administration took control of the Executive Branch of the federal government, and it has signaled that it will make aggressive use of executive orders....more

Supreme Court Removes a Major Hurdle for Administrative Agency Rulemaking

On March 9, 2015, the Supreme Court ruled unanimously that when a federal administrative agency wants to amend or repeal an “interpretive rule,” it does not have to follow the notice-and-comment procedures set forth in the...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

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