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    EMA Tells Pharma Companies to Continue to Prep for UK’s Withdrawal

    With an extension in place that will push the UK's withdrawal from the EU back to either April or May, the European Medicines Agency (EMA) told pharmaceutical companies on Monday to continue their preparations for Brexit. Under the European Council decision from last Friday, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. But if the withdrawal agreement is not approve...
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    CBER Finalizes Guidance on Use of Standards in Regulatory Submissions

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday finalized guidance on the use of standards in product development and the use of such standards in CBER’s review process. The 10-page guidance, finalizing a draft from December 2017 , offers a series of questions and answers ranging from “What is a standard?” to “How are voluntary standards developed?” to “What is CBER’s policy on accepting standards used in regula...
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    Natural History Studies for Rare Diseases: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Friday published new draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of treatments for rare diseases. Specifically, the 19-page draft describes the potential uses of a natural history study in all phases of drug development for rare diseases. It covers the strengths and weaknesses of various types of natural history study designs, common data e...
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    EMA on Brexit: Risk for Drug Shortages Decreases

    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”   The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized me...
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    Reorganization of FDA’s Office of the Commissioner to Begin Soon

    Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND). With an eye toward efficiency and better connecting the Office of the Commissioner with center directors and other office leadership, outgoing FDA Commissioner Scott Gottlieb said in an email to staff on Thursday that the reorganization plan “elevates the role of the Ce...
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    To Prevent Losartan Shortages, FDA Allows Higher Impurity Levels

    To ensure patient access to the blood pressure medicine losartan, the US Food and Drug Administration (FDA) said late Wednesday that it will not object to certain manufacturers temporarily distributing losartan with one impurity above the interim acceptable intake limit until that impurity can be eliminated. For such companies, losartan “containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the  interim acceptable intake limit  of 0.96 parts per million (ppm) a...
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    UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs

    With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place. On Wednesday, the MHRA published guidance on registering clinical trials, publishing trial results, future trial transparency efforts and the process for applicants applying for a Pediatric Investigation Plan (PIP), waiver, deferral or product-specif...
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    OMB Reviews Proposal to Add Prices to Pharma TV Ads

    The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements. The rulemaking, now one step closer to finalization in some form, was released by the Centers for Medicare and Medicaid Services (CMS) last October and seeks to further shine a spotlight on drug and biologic prices, with the hope of reducing prices in the process. HHS Secretar...
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    EU Publishes First Corrigenda for MDR, IVDR

    As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda. Although the documents do not alter the transition deadlines for companies (some had hoped there might be a break for struggling class I device companies), the corrigenda do offer a look into areas of the regulations where there may have been confusion...
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    Biosimilar Groups Offer Proposals to Help US Better Mirror EU Successes

    With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups from the US and EU on Tuesday called for several structural changes so that the US can see the same competitive environment that Europe currently enjoys. Specifically, the Biosimilars Forum and Medicines for Europe are calling for: “a fair market that allows those products that initiate lower prices to gain market share”; “a strong biosimilars pipeline with scientifically-sound a...
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    New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

    With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday and Tuesday released 16 new and updated guidance documents, mostly related to marketing authorizations, variations and licensing. A couple of the guidance documents deal with how MHRA will authorize new medicines in the event of a no-deal Brexit, including guidance on how the agency will handle centraliz...
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    FDA Finalizes Two Guidances on HIV Drug Development

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents to support the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients and to aid the development of systemic drugs for the prevention of HIV-1 infection. The guidance from FDA comes as the agency has approved 29 drugs to treat HIV infection. FDA Commissioner Scott Gottlieb said in a statement that the guidance...