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Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-...
    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 stature as the global “gold standard” in drug regulation. Maintaining that standard requires us to...
    “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...

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