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    EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

    European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio. Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implement...
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    CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns

    The US Food and Drug and Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday convened its Patient Engagement Advisory Committee (PEAC) to discuss the difficulties and challenges in communicating cybersecurity safety risks and threats. Since 2013, CDRH has released safety communication related to eight device cybersecurity concerns, although the center notes that issues are customarily disclosed when there is a software update to fix an is...
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    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
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    US Government Wants to Know More About the Biotech Ecosystem

    The White House’s Office of Science Technology and Policy (OSTP) on Tuesday sought input from any and all biotech stakeholders on the innovation, products, technology and data derived from biologically-related processes and science that drive economic growth, promote health and increase public benefit. Referred to as the “Bioeconomy,” OSTP said it’s seeking comments before 23 October from the public, including those with capital investments, those performing research or...
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    FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

    The US Food and Drug Administration (FDA) said Monday that an inspection of an outsourcing facility uncovered information about 4,202 adverse events linked to compounded hormone pellets that had never been reported to the agency. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement that the mishap highlights the need for compounders of drugs and other affiliated organizations to report adverse events promptly.   “The adver...
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    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...
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    Novartis Makes New Data Integrity Commitment

    Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the US Food and Drug Administration (FDA). “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible all...
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    EMA Begins Review of Skin Cancer Data for Patients Using Picato

    EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday announced that it’s begun reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, which is a skin condition caused by excessive sun exposure. The review, which will run until January 2020, was triggered by data from several studies showing a higher number of skin cancer cases including cases of squamous cell carcinoma in patients using Picato, EMA ...
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    De Novo Requests: FDA Finalizes Three Guidances

    The US Food and Drug Administration (FDA) on Friday finalized three guidance documents related to de novo classification requests for medical devices. Devices using the de novo classification process are those for which there is no predicate device to rely on, and devices granted a de novo request can serve as a predicate device for a later 510(k) submission. So far in 2019, CDRH has granted 15 de novo requests, which compares with 44 requests granted in 2018 and 31 in ...
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    Humanitarian Device Exemptions: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the Humanitarian Device Exemption (HDE) program, reflecting changes made by the 21 st Century Cures Act and further explaining the criteria to determine “probable benefit” related to its decision-making process for humanitarian use devices (HUDs). HUDs are medical devices intended to help treat or diagnose diseases or conditions that affect or are manifested in not more than 8,000 individual...
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    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
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    Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

    As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...