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FDA Warning Letters › Premarket Approval Applications › Food and Drug Administration (FDA)

Troutman Pepper

En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

Troutman Pepper on

In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more

Wilson Sonsini Goodrich & Rosati

Court Holds the FDA Cannot Classify an Imaging Agent Medical Device as a Drug

Wilson Sonsini Goodrich & Rosati on

The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more

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