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Response Biomedical Corporation announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to market the RAMP NT-proBNP Test as an aid to the rapid diagnosis of heart failure (HF). Read More...
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Premier Research Group, an international pharmaceutical services company, received International Organization for Standardization (ISO) 13485:2003 certification for its global medical device operations. Read More...
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Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced yesterday in the House to preserve state product liability lawsuits. Read...
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Impliant has resumed European clinical trials with its TOPS system, a total posterior arthroplasty device used to treat spinal stenosis. Read More...
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The Center for Devices and Radiological Health (CDRH) is continuing its efforts to use information from other healthcare regulators to enhance its risk assessments of manufacturing facilities, according to an FDA director. Read More...
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Rep. Rosa DeLauro (D-Conn.) is urging the FDA’s Science Board to expand its inquiry of bisphenol A (BPA) to include medical devices. Read More...
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InterCure Ltd., a medical device company publicly traded on the Tel-Aviv Stock Exchange, announced the findings of new studies and analysis highlighting RESPeRATE — the only medical device cleared by the FDA and CE-approved for the treatment of hypertension...
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Some device, drug and biologic product applications and submissions to the U.S. Food and Drug Administration (FDA) that are not related to clinical trials may not need the certification specified in the FDA Amendments Act of 2007 (FDAAA), the agency says...
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While the European Commission (EC) is seeking comment on ways to overhaul the European Union’s Medical Device Directives, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking suggestions on drafting regulations to transpose those...
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Congress is turning up the heat on a preemption win for devicemakers as prominent lawmakers say they will soon introduce a bill to make the U.S. Supreme Court decision moot. Read More...
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While the U.S. Supreme Court is scheduled to hear a case in its next session on preemption for state lawsuits against a pharmaceutical manufacturer, key legislators are taking steps to block the court’s ruling on medical device preemption. Read More....
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The California Senate passed a bill that would allow pharmacies to sell patient information to third-party marketers, including drug companies. It was sent to the California Assembly for consideration. Read More...
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In his blog, Mark Senak writes about direct-to-consumer advertising and the potential for internet sites like YouTube to become a new medium. Read More...
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One in 10 U.S. medical schools surveyed by the American Medical Students Association (AMSA) have no policies on financial conflicts of interest with drug companies or policies the group deemed unacceptable, earning them a grade of F. Read More...
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