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    EU Commissioner for Health: MDR’s May 2020 Deadline Won’t Change

    Despite concerns raised by both the medical device industry and EU member states that the 26 May 2020 deadline for the Medical Devices Regulation (MDR) is unfeasible, European commissioner for health Stella Kyriakides said Monday that the deadline will not change. Echoing her predecessor’s comments from last June , Kyriakides said at a press conference following the meeting of the EU’s Employment, Social Policy, Health and Consumer Affairs Council that “a lot of work n...
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    Court Rules Against FDA’s Finding That a Device was a Drug

    Whether the US Food and Drug Administration (FDA) classifies a product as a drug or a device can have huge implications for the sponsor, partly because of how the agency reviews the different products and partly because of the increased cost of bringing a drug to market. For Missouri-based Genus Medical Technologies’ contrast agent Vanilla SilQ, which people drink before undergoing an X-ray, the US District Court for the District of Columbia recently ruled that FDA made...
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    US Biosimilar Launches About to Turn a Corner

    The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009. Ten years later (or less than five years since the first FDA approval of a biosimilar), and just 42% (11 out of 26) of FDA-approved biosimilars have launched. But in the next three months (see chart below), a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake. For instance, Pfize...
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    FDA Sends Untitled Letter to Company Marketing Stem Cell Treatment for Autism

    The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions with few treatment options. FDA says the product appears to be a human cell, tissue, or cellular or tissue-based product (HCT/P) and the company’s website notes a few stories that suggest the stem cell treatment may help children ...
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    FDA to Heartburn Drug Manufacturers: Do Not Release Lots if NDMA is Above Acceptable Levels

    As manufacturers of popular heartburn drugs, like Zantac, continue to pull their products from shelves, the US Food and Drug Administration is now telling the companies to test their drugs for an impurity, known as N-nitrosodimethylamine (NDMA), before making them available. The new requirement comes as earlier last month FDA noted that although many of these NDMA levels observed via FDA testing are much lower than the levels some third-party scientists first claimed,...
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    House Likely to Pass Pelosi’s Drug Pricing Bill Next Week

    House Speaker Nancy Pelosi (D-CA) and Democrat colleagues said they will pass a wide-ranging drug pricing bill that many in the pharmaceutical industry have warned would be catastrophic. However, the bill is unlikely to make headway in the Republican-controlled Senate and President Donald Trump has already said he opposes the bill. “We have now received enough guidance from CBO to bring the Lower Drug Costs Now Act to the Floor and to reinvest its savings in one of the ...
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    EC Offers Technical Guidance on UDIs

    The European Commission on Wednesday released eight documents related to the technical specifications for unique device identifiers (UDIs). Four of the documents are related to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose, risk class, design and manufacturing characteristics, and which are required elements for the incoming device database, known as Eudamed. The four Basic UDI-DI documents are from GS1, HIBCC, ICCBBA an...
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    Lawmakers Reiterate Call to Integrate UDIs With Insurance Claim Forms

    Senate Finance Committee Chairman Chuck Grassley (R-IA) joined Sen. Elizabeth Warren (D-MA) and three representatives to support the integration of the device identifier portion of unique device identifiers (UDIs) with electronic health insurance claims forms.  The integration is necessary as currently, when a device fails or is recalled, it can be difficult to identify which patients are affected. And whereas FDA can monitor drugs and vaccines on the market, the agency...
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    FDA Debates Creating Pilot to Evaluate Novel Excipients

    The US Food and Drug Administration (FDA) on Wednesday sought comments on whether it should run a voluntary pilot program to evaluate the toxicology and quality of novel excipients. While the agency does currently review new excipients as part of an investigational new drug application (IND) or a marketing application (NDA or BLA), FDA explains how certain novel excipients may provide public health benefits, such as improved drug delivery or utility in abuse-deterrent o...
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    FDA Sends Warning Letter to Texas Device Sterilizer

    The US Food and Drug Administration (FDA) sent a warning letter to the Houston site of the medical device manufacturer and sterilizer American Contract Systems after raising questions about complaints related to bugs found inside supposedly sterile bags. During the inspection last September and October, FDA said it observed that six out of 12 complaints reported between 2017 and 2019 were related to bugs on the inside of sealed sterilized bags, and in one of the instanc...
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    European Parliament Committee Signs Off on Second Round of MDR, IVDR Corrigenda

    With less than six months left before the Medical Devices Regulation (MDR) takes effect, the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday voted to adopt a corrigendum that will give manufacturers of certain up-classified Class I devices an additional four years to comply. The delay for some low-risk devices that will need to use a notified body, which sets the new deadline at 26 May 2024 , was expected, as a proposal was ...
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    Senate Committee Advances Nomination of Hahn as FDA Commissioner

    The Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday voted 18 to 5 to advance the nomination of Stephen Hahn to be the next US Food and Drug Administration (FDA) commissioner. HELP Committee Chairman Lamar Alexander (R-TN) pledged his support for Hahn and said he hopes the full Senate will vote on Hahn’s nomination by the end of the month. Ranking member Patty Murray (D-WA) raised questions about Hahn’s commitment to safety with respect to tob...