AG/FDA Blog

Device Firms: What You Should Know About The 21st Century Cures Act

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and C… Read More
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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Condu… Read More
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