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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
Posted 22 April 2014 | By Alexander Gaffney, RAC,
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 Act (FD&C Act) in recent memory.
One alleged fugitive, Dushyant Mehendrabhai Patel, reportedly headed up a North Carolina-based company which sold pre-filled heparin syringes without first conducting sterility testing despite providing assurances that his company had done so. The products were ultimately associated with at least five deaths and hundreds of other injuries requiring hospitalization, FDA said.
Other fugitives contained on the list are reported to have imported counterfeit drugs, marketed mislabeled and unapproved drugs, and diverted and resold pharmaceuticals.
Each profile of a reported fugitive contains a mugshot, a brief case history and the person's name, age and national origin.
FDA Most Wanted Page
Tags: Office of Criminal Investigations, Most Wanted, Fugitive, OCI, Latest News
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