May 25, 2012 | Vol. 4 No. 21
CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative — which aims to create an ongoing culture of quality at medical device manufacturers.
Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance.
As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.
Corrective and preventive action (CAPA) procedures used to address equipment failures during batch tests at ALK-Abello’s flagship facility are inconsistently applied, an FDA Form 483 states.
Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant.
Pfizer is recalling more than half a million bottles of OTC headache drug Advil Liqui-Gels after customers complained of strong product odors and mildly troubled tummies, the drugmaker says.
A project manager at Diamond Wipes’ Chino, Calif., facility bypassed its quality control unit and allowed products deemed unfit for release to be shipped for sale anyway, a Form 483 states.
The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification for its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product.
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