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Notice and Comment Food and Drug Administration (FDA) Regulatory Requirements

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

Genova Burns LLC

The ABC's of CBD Regulation

Genova Burns LLC on

“Isn’t hemp the same thing as cannabis (marijuana)?” The difference between cannabis and hemp stem from their most widely studied and commonly known chemical compounds: tetrahydrocannabinol (“THC”) and cannabidiol (“CBD”)....more

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