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  • Regulatory NewsRegulatory News

    After FDA's Top Cop Leaves, Agency Looks for Replacement

    The US Food and Drug Administration (FDA) is looking for a new director for its Office of Criminal Investigations (OCI), it announced on Thursday. The OCI is FDA’s criminal enforcement wing, charged with going after suspected violators of the  Federal Food, Drug and Cosmetic Act . The 29 May 2014 announcement on the government's federal jobs board, USAJobs.gov, explains that the agency is looking for someone who can develop and direct its criminal investigation activi...
  • America's (Other) Most Wanted: FDA Takes Aim at Drug and Device Fugitives

    The US Food and Drug Administration (FDA) is taking a page from the Federal Bureau of Investigation (FBI) in the hopes of tracking down some of the most egregious violators of federal food and drug law. On 15 April 2014, FDA's Office of Criminal Investigations (OCI), FDA's criminal enforcement division, launched a "Most Wanted Fugitives" page complete with 11 profiles of fugitives purported to be behind some of the worst violations of the Federal Food, Drug and Cosmetic...
  • FDA Looks to Big Data to Assist Off-Label Marketing Investigations

    The US pharmaceutical industry has long been known to aggressively market its products, and not always in a scrupulous fashion. Now a new notice posted on the Federal Business Opportunities (FBO) website indicates that federal regulators with the US Food and Drug Administration (FDA) are preparing to buttress their investigations using real-time, big data approaches previously only used for postmarketing safety assessments. The solicitation , which was first posted on t...
  • FDA Getting New Director of Office of Criminal Investigations

    The US Food and Drug Administration (FDA) is getting a new Director of its Office of Criminal Investigations (OCI), reports Main Justice . John Roth, a 25-year veteran of the Department of Justice and currently a member of its Financial Action Task Force, will assume the position of Director, where he will supervise a staff of 280 FDA personnel. The OCI is FDA's criminal enforcement wing, charged with going after suspected violators of the Federal Food, Drug and Cosme...