3rd Circuit: Unapproved Drug Ingredient Doesn’t Create ‘New Drug’ Liability

(July 31, 2023, 8:24 AM EDT) -- PHILADELPHIA — The Third Circuit U.S. Court of Appeals affirmed a trial court ruling that a generic drugmaker’s failure to disclose active ingredients from an unauthorized supplier did not constitute the introduction of a “new drug” in criminal violation of the Food, Drug and Cosmetic Act....