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    EMA Extends Valsartan Review to Include Four More Active Substances

    The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”   The move to include candesartan, irbesartan, losartan and olmesartan in the ongoing review was prompted by the detection of “very low levels of N-nitrosodiethylamine (NDEA)” in the losartan products manufactured by Hetero Labs in India, EMA sai...
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    DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity

    A new work item on cybersecurity was proposed at the International Medical Device Regulators Forum (IMDRF) management committee hearing this week in Beijing, China by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).   Pending the outcome meeting statement to be released by IMDRF chair China Food and Drug Administration, DITTA chair Patrick Hope told Focus that the proposed new work item is centered on three areas of cybersec...
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    FDA Previews Patient-focused Report on Opioid Use Disorder

    The US Food and Drug Administration (FDA) offered a sneak peek Thursday into a new report on the impact of opioid use disorder (OUD) from the perspectives of about 155 patients.   The report is set to be released later this year, said FDA operations research analyst Sara Eggers during a joint public workshop between the agency and the Duke Margolis Center for Health Policy at the National Press Club in Washington.   Preliminary results highlighted by Eggers offer i...
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    EMA’s CHMP Appoints New Chair Ahead of Brexit

    The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) announced Wednesday its vice-chair—the German Federal Institute for Drugs and Medical Devices’ (BfArM) Harald Enzmann—will soon become its new chair.   Enzmann will replace Tomas Salmonson, a scientific advisor at the Swedish Medicinal Products Agency, who has reached the maximum of two three-year mandates as chair. Salmonson took the helm in 2012 after the previous chair...
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    CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued final guidance Wednesday to aid manufacturers in reducing the risk of patient injury associated with heparin-containing medical devices and combination products.   The final guidance, which is largely consistent with the draft version from 2015, aligns CDRH policies with the US Pharmacopeia (USP) drug substance and product monographs for heparin sodium, heparin lock flu...
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    Updated: FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

    A recent US Food and Drug Administration (FDA) draft guidance on a requirement under the Risk Evaluation and Mitigation Strategy (REMS) program for pharmaceutical sponsors was met with mixed reactions from a Rutgers law professor and Novartis in new comments.   The draft guidance that set the stage for how sponsors' requests for waivers of the single, shared system (SSS) requirement would be evaluated by FDA was issued earlier this year, along with a separate guidanc...
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    FDA Extends REMS Requirements to Immediate-Release Opioids

    On the heels of the sweeping opioid legislation package that passed the Senate on Monday, the US Food and Drug Administration (FDA) expanded its Risk Evaluation and Mitigation Strategy (REMS) program to include all immediate-release opioid analgesics intended for outpatient use.   Manufacturers of extended release and long-acting opioid analgesics have been subject to the requirements under the Opioid Analgesic REMS since 2012, which is when the initial shared systems ...
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    Device Firms in Puerto Rico Look to Learn from Hurricane Maria’s Aftermath

    With Hurricane Maria’s anniversary approaching, medical device firms in Puerto Rico are reflecting on lessons learned to mitigate the impact of any future natural disaster on supply and quality.   The devastation that the hurricane wrought is reflected in Puerto Rico’s death toll, with the estimates reaching a total of 2,975 residents. But the experience of having to operate below capacity and on generator power presented some unique challenges that some firms see as...
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    Australia Unveils Strategy for Engaging With Foreign Regulators

    Australia’s Therapeutic Goods Administration (TGA) revealed a three-part plan on Monday to operationalize its strategy on engaging international regulators through FY 2019. TGA said the new plan “identifies projects and activities, the benefits to be realized from those activities, and the line areas responsible for delivering on the three goals for international engagement:” Contribute to public health and safety through regulation, work with others to improve the re...
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    FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

    The US Food and Drug Administration (FDA) issued a safety communication on Friday to alert of a potential risk of eye damage in patients who have Alcon's CyPass micro-stent implanted.   The notice follows on the heels of last month’s announcement from Alcon—Novartis’ eye care unit—voluntarily withdrawing all versions of its CyPass micro-stent from global markets.   Both the market withdrawal and the safety alert are based on the findings from a post-approval ...
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    Lawmakers Halt Push for Drug Prices in TV Ads

    In an effort to get the first set of FY 2019 appropriations bills to the President’s desk, US House leaders scrapped a bipartisan amendment that would have required drugmakers to include list prices in direct-to-consumer (DTC) television ads. The amendment—sponsored by Sens. Dick Durbin (D-IL) and Chuck Grassley (R-IA)—was offered and subsequently withdrawn during a joint conference committee of the House and Senate, despite passing the Senate last month. The move was...
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    Appropriate Use of Consensus Standards: FDA Issues Draft and Final Guidance

    To further promote international harmonization of device regulations, the US Food and Drug Administration (FDA) finalized guidance to aid manufacturers in appropriate use of voluntary consensus standards and issued draft guidance on the recognition and withdrawal process. The final guidance was slightly modified for further clarifications on the regulatory framework drafted in 2014 guidance. These changes include a new section on appropriate use when devices or standard...