Debarment is a penalty set forth in a 1992 amendment to the Food and Drugs Act, which the U.S. Food and Drug Administration can, and sometimes must, impose on persons or companies that engage in criminal conduct with respect to the development or approval of new drugs. The penalty itself is a prohibition against that person or company from submitting or assisting in the submission of such an application.

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  • Debarment is a penalty set forth in a 1992 amendment to the Food and Drugs Act, which the U.S. Food and Drug Administration can, and sometimes must, impose on persons or companies that engage in criminal conduct with respect to the development or approval of new drugs. The penalty itself is a prohibition against that person or company from submitting or assisting in the submission of such an application. By statute, it only applies to applications for approval of new drugs, and not to applications for other approvals granted by the FDA, such as changing a prescription drug to over-the-counter status, or approving a new food additive. As of April 2009, the FDA has debarred 73 persons, an average of less than five per year, of which all but 9 were permanently debarred. The FDA has never debarred a company.
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  • Social rejection
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  • the U.S. Food and Drug Act penalty
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  • the sociological concept
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  • Debarment is a penalty set forth in a 1992 amendment to the Food and Drugs Act, which the U.S. Food and Drug Administration can, and sometimes must, impose on persons or companies that engage in criminal conduct with respect to the development or approval of new drugs. The penalty itself is a prohibition against that person or company from submitting or assisting in the submission of such an application.
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  • Debarment
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