Pharmaceutical and medtech executives responsible for assuring compliance with relevant US Food and Drug Administration regulations for products manufactured by their companies may face increased “misdemeanor prosecutions” if they fall short in their designated role.
An internal FDA committee comprising senior leadership, including the Office of the Commissioner, the Office of Chief Counsel and the Office of Criminal Investigations (OCI), has recommended that the agency “increase the appropriate use of misdemeanor prosecutions,” providing a valuable enforcement tool to hold responsible corporate officials accountable, FDA commissioner Margaret Hamburg says in a letter to congressman Chuck Grassley (Republican – Iowa)1...
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