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The number of devicemakers that received warning letters from the U.S. Food and Drug Administration following quality system inspections decreased 12 percent in 2013, compared with the previous year — the first decline since 2009. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More
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