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The FDA recently issued a warning letter to Ohio-based drug manufacturer Gentere for allegedly compounding nonsanctioned copies of commercially available drugs.
The FDA issued a warning letter July 22 to New York-based contract packaging firm Ultra-Seal for violating numerous cGMP standards, including inaccurate labeling on several lots of ephedrine tablets.
Launched just seven months ago, the FDA’s dispute resolution process (DRP) pilot program is already starting to show some major benefits, Center for Drug Evaluation and Research (CDER) official David Horowitz told DGR in a recent interview.
Acting FDA Commissioner Lester Crawford confirmed last week that the unveiling of the agency’s highly anticipated overhaul of pharmaceutical GMPs would occur within the next several months.
Pacemakers and newer implantable cardioverter defibrillators (ICDs) do not pose the same electromagnetic interference problems to magnetic resonance imaging (MRI) scans that many predecessor devices do, according to a recent study.
Research activities continue to be a target of enforcement efforts by the FDA, which last week published two more warning letters issued to clinical investigators (CIs).
Correlogic Systems has decided to move a software program for its OvaCheck ovarian cancer-screening tool in-house to avoid submitting a premarket approval (PMA) application for the program. The decision follows an FDA ruling that classified the program as a medical device.