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Drug and device manufacturers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
The FDA expects to release rules on international clinical trials by the end of next year, according to HHS’ 2015 agenda, which was unveiled Nov. 24. Read More
BioMerieux received an FDA warning letter for its handling of complaints and nonconformances, including applying roughly 546 complaint description codes that are not defined in company documents. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More
Devicemakers need to be vigilant against potential vulnerabilities embedded in medical device software as the FDA continues to formulate its cybersecurity strategy, a security expert warns. Read More
Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to a recent report by Stericycle. Read More