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Third Circuit Tosses Criminal Charge that Unauthorized Ingredient Source was Introduction of a “New Drug” 

Drug & Device Law

July 20, 2023), was decidedly unpleasant for the government – specifically, the Food and Drug Administration. The government prosecuted a drug company and its executives for sourcing an active ingredient from a facility not included in the drug approvals, and for lying about it. The company was also tagged with a count of mail fraud.

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