FDA Compliance

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Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our...
    “I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars...
    The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight Medical...
    Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in...
    In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance...

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