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While Sept. 24 might seem far off, the FDA is urging labelers not to be complacent in meeting that target date for submitting necessary information into the Global Unique Device Identification Database. Read More
The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
Industry and the FDA appear to be far from reaching an agreement on the fourth iteration of the Medical Device User Fee Act, based on newly released meeting minutes posted last week. Read More