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    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
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    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...
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    Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk

    The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach. The widely used OTC products already have warnings  about this bleeding risk in their labels, though Dr. Karen Mahoney, Deputy Director and Supervisory Medical Officer in FDA’s Division of Nonprescription Drug Products, noted that a r...
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    Congressmen Question FDA Over Office of Laboratory Safety

    Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or level of staffing for its Office of Laboratory Safety. The letter follows an April hearing at which FDA said it has taken “direct and definitive actions” to improve lab safety. That hearing came as a report fro...
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    FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

    The US Food and Drug Administration (FDA) on Thursday advised that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections (UTIs) who have other treatment options. “For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options,” the agency said in its safety notification. ...
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    Three FDA Final Rules Slated for Release in May

    Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products. Device Trial Data The final rule on medical device clinical s...
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    Drug Safety Reports Still Uninformative, FDA Officials Say

    Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article. Sponsors are required to compile all adverse events for drugs they are studying in annual safety reports. If an adverse event is serious, unexpected or suspected to be caused by the drug being studied, sponsors are required to submit an expedited report to FDA within 15 days ...
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    Antipsychotic Label Updated With New Impulse-Control Side Effects

    • 03 May 2016
    The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. “These uncontrollable urges were reported to have stopped when the medicine was disconti...
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    New Studies Push FDA to Expand Label for Popular Diabetes Drugs

    Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was stro...
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    FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

    The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. FDA has added new warnings to the following drug labels about this safety issue: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release) Takeda’...
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    Report Outlines New FDA Device Evaluation System, Coordinating Center

    A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts. Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, i...
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    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...