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FDA Warning Letters Administrative Procedure Act

Troutman Pepper

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Troutman Pepper

Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

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On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...more

Troutman Pepper

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

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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

FDA Releases Table of Gene-Drug Interactions amid Ongoing Clash over Pharmacogenetics Tests

Pharmacogenetics, although in its infancy, has the potential to help predict how individual patients will respond to a given drug. Pharmacogenetics (or pharmacogenomics) is the study of "how genes affect a person's response...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Cannabidiol Marketing Warning as Congressional Pressure for Action Continues

Following through with its promise to take enforcement actions against companies marketing cannabis-derived products that could put consumers at risk, the Food and Drug Administration (FDA) recently issued a warning letter to...more

Latham & Watkins LLP

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

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FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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