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Melinda Plaisier

Associate commissioner for regulatory affairs

U.S. Food and Drug Administration

Melinda Plaisier is the associate commissioner for regulatory affairs at the Food and Drug Administration. She leads more than 4,300 employees and operations in the Office of Regulatory Affairs (ORA). Plaisier helps the FDA adapt to the continuing program-based and in implementing FDA’s expanded authority. Prior to FDA Plaisier worked for 13 years in the U.S. Congress for the Office of the Commissioner directing and managing the agency’s congressional relations and legislative activities. She also served as the associate commissioner for international programs where she focused on negotiating international agreements and working with developing nations.

Wed, 12/24/2014 - 00:00
When Inspections and Regulations Leave Quality Lacking, Try ThisA Case for Quality is changing medical device manufacturers focus and FDA’s approach
Wed, 12/02/2015 - 16:33
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified…
Regulators Caught in the Act of Protecting Public HealthFDA field inspectors take quality control with them
Wed, 12/24/2014 - 00:00
  We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live…
      

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