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Notice and Comment › Regulatory Reform › Regulatory Requirements

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

Faegre Drinker Biddle & Reath LLP on

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Morgan Lewis

HHS Rescinds Policy Extending Notice and Comment Rulemaking Procedures to Rules for Grants, Public Benefits, and Contracts

Morgan Lewis on

Effective March 3, 2025, the US Department of Health and Human Services (HHS) rescinded its long-standing policy that had waived a statutory exemption under the Administrative Procedure Act (APA) from notice and comment...more

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