Regulatory Affairs

21
Jun

FDA Means Business on Unapproved Drugs – If You Don’t Believe It, Just Wait and See!

At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs. The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs. Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.

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