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Declaratory Judgments Food and Drug Administration (FDA) Regulatory Requirements

Troutman Pepper Locke

FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO

Troutman Pepper Locke on

On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its...more

Venable LLP

Spotlight On: Biosimilar Litigations - March 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

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