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    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...
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    FDA Bars Use of 24 Ingredients in Antiseptic Washes

    The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings. The rule was first proposed in 2015 , and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule. "Ensuring the safety and effectiveness of over-the-counter h...
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    European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Quality of Inhaled Pharmaceutical Products The European Medicines Agency (EMA) has started a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. EMA published the concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its cu...
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    FDA Delays Final Rule on Intended Uses

    The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices. The petition, filed by on behalf the Medical Information Working Group (MIWG), the Pharmaceu...
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    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
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    Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases

    The US Food and Drug Administration (FDA) on Thursday amended its current good manufacturing practice (CGMP) and labeling regulations for medical gases. The changes come as the agency cites “a number of incidents” where medical gas containers holding gases other than oxygen were erroneously connected to a health facility’s oxygen supply system, leading to serious injuries and deaths. “The final rule is intended to increase the likelihood that the contents of medical g...
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    FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database

    As part of efforts to reduce an increasing number of adverse events from home-use medical devices, the US Food and Drug Administration (FDA) is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.  The shift comes as FDA reviewers claim that the agency receives reports of approximately three to five of the most serious types of adverse events (deaths, fires, explosions...
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    FDA Amends Definition of Custom Device

    The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...
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    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
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    FDA Pushes Back Enforcement of UDI Rule Provisions

    The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time. The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and proces...