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Classification Regulatory Standards

Foley Hoag LLP - Cannabis and the Law

4th Circuit Challenges DEA’s Findings on the Legality of Certain Hemp Derived Cannabinoids

The United States Court of Appeals for the Fourth Circuit ruled that the Drug Enforcement Agency’s (“DEA”) classification of certain hemp-derived cannabinoids as unlawful was not entitled to deference, given that the language...more

Dickinson Wright

Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products

Dickinson Wright on

Originally published in Healthcare Michigan, Volume 41,  No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

Butler Snow LLP on

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Mitchell, Williams, Selig, Gates & Woodyard,...

The Benefit of Achieving Tier III Classification for Marijuana and Cannabis Related Businesses

In 2020 the legal segment of the marijuana industry exceeded $10 billion dollars in the United States with California alone generating $3.1 billion in sales in 2019, and Colorado in a close second at $1.6 billion. With the...more

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