News & Analysis as of

Regulatory Authority Rulemaking Process Food and Drug Administration (FDA)

Epstein Becker & Green

A Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices

As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more

Faegre Drinker Biddle & Reath LLP

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

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

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

Venable LLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Womble Bond Dickinson

Proposed California CBD Class Action Stayed: Primary Jurisdiction Doctrine Again Halts a CBD Suit

Womble Bond Dickinson on

As the CBD industry continues to wait for the U.S. Food and Drug Administration (FDA) to begin the rulemaking process for the regulation of cannabis-derived products — which will hopefully provide some clarity regarding how...more

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