Implant Quality Lapses Fuel Push for More Devicemaker Data; Learn What's Under Consideration
While judging the Medicines and Healthcare products Regulatory Agency's (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future. The MHRA "fulfilled its obligations" in pursuing French devicemaker Poly Implant Prosthese about incidents involving its product and sought to determine the cause and extent of the problems being reported, the review states. "However, it is also clear that these investigations were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products," Earl Howe, parliamentary under-secretary of state for quality in the DOH, writes. . . .
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FDA Gears Up To Boost Inspectorate Skillset in One Critical Area
A new government report has cast doubt on the FDA's ability to handle information associated with the rising flood of drug imports, saying its sluggishness in integrating legacy IT systems is limiting regulatory effectiveness. Compounding matters is its lack of a comprehensive list of existing and planned IT systems, according to the recent Government Accountability Office (GAO) analysis. And foot-dragging on standing up its largest mission-critical system modernization project -- the Mission Accomplishments and Regulatory Compliance Services (MARCS) legacy systems replacement program -- is of paramount concern, the report states. . . .
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