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The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More
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