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    FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors

    Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...
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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    The US Food and Drug Administration (FDA) on Friday published new draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of treatments for rare diseases.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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    EU MDR/IVDR Coordination Group Urges Exemption Clarification

    The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification of Article 54(2)b is “extremely urgent.” The Medical Devices Coordination Group (MDCG) evaluated the three criteria in Article 54(2) of the EU’s medical device regulation (MDR), which will exempt certain class III and class IIb devices from the requirement to involve expert panels in premarket clinical evaluation c...
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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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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
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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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    FDA’s OCP Works to Modernize Review Functions

    Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP) in 2018 and will be used to prepare for 2019 priority areas related to the opioid crisis, antimicrobial resistance and rare diseases. OCP, within the Center for Drug Evaluation and Research (CDER), outlined newly implemented steps for modernizing review functions in its recently released annual ...
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    EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Holds off Backlash Against ‘Extraordinary Power Grab’ on Drug Shortages   The United Kingdom government has resisted an attempt to revoke changes to the handling of drug shortages. An opposition politician called the serious shortage protocol reforms an “extraordinary power grab” but was unable to rally enough support in parliament to get the changes r...
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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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    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...