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Scott Gottlieb
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations...
    Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified...
    What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS. Historically, regulations have almost...
    I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device...
    QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look: “What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern...

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