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    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
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    Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications

    When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public be considered in violation of the law or US Food and Drug Administration (FDA) regulations? FDA on Wednesday attempted to answer these questions and more with the release of two new draft guidance documents and a 63-page memorandum on public health interests and First Amendment considerations related to off-label communica...
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    FDA Begins Process of Overhauling Off-Label Communications Regulations

    The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices. The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District C...
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    GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

    The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers. On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority...
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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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    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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    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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    Health Canada Details New Confidential Info Disclosures in Draft Guidance

    Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance. The disclosure of such CBI, approved under the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law) of 2014, stipulates that the Minister of Health may disclose CBI “about a therapeutic product without notifying the person to whose...
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    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...
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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...