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Hogan Lovells

State Licensing Spotlight – Prescription Medical Device Manufacturers & Distributors: Enforcement and penalties for operating...

Hogan Lovells on

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more

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

Hogan Lovells

French simplifies regulations applicable to health care activity authorizations; health cooperation groups now entitled to hold...

Hogan Lovells on

The long-awaited Valletoux decree regularizes the exclusion of health cooperation groups for the ownership of certain health care activities’ authorizations in France, resulting from the 2022 reform of health care activities....more

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