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Expert Analysis

2018 FDA Enforcement Review: Drugs, Biologics And Devices

By Greg Levine, Beth Weinman and Scott Falin (January 28, 2019, 12:30 PM EST) -- While some government agencies appeared to be rolling back regulations and ramping down enforcement efforts in 2018, the U.S. Food and Drug Administration was not among them. The FDA worked closely with partner federal agencies throughout the year, deploying the full array of its enforcement tools — administrative remedies, along with criminal and civil actions — to advance the agency's public health mission. This year-end lookback reviews FDA enforcement activity around drugs, biologics and devices and assesses the FDA's top enforcement priorities as we look forward to 2019.[1]...

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