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    SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

    In cases where state failure-to-warn claims should be dismissed as pre-empted by federal law, the Supreme Court on Monday unanimously ruled that judges, rather than juries, are better equipped to evaluate the nature and scope of an agency’s, such as the US Food and Drug Administration (FDA), determination. While ruling that a lower court should re-assess its decision on the Merck case related to the labeling for a drug’s side effects, the majority opinion also noted: “[...
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    FDA Officials Explain When Litigation Can Impact Drug Safety Signals

    The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an impact on detecting safety signals, Monica Muñoz and Gerald del Pan of FDA’s Office of Surveillance and Epidemiology wrote recently in a research letter to the journal Drug Safety . The letter came in response to a study in the same journal that found lawyer-submitted reports in FAERS did not meaningful...
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    UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

    In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a little more than a year to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). Under the pilot, which has been run jointly since April 2018 by the UK’s Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA), a sin...
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    Groups Seek More FDA Flexibility in Early Cell Therapy Development

    A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.   In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) T-cell therapies have shown promise in treating a wide range of cancers. To date, FDA has ap...
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    FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

    In line with efforts to assess the impact and sources of the sartan safety scandal, India-based Torrent Pharmaceuticals and Cadila Healthcare separately drew lengthy US Food and Drug Administration (FDA) Form 483s over, among other issues, failures to thoroughly review unexplained discrepancies. The manufacturing site inspection at Torrent Pharmaceuticals FDA investigators conducted over the course of about a week last month resulted in four inspectional citations, with...
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    Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks, FDA Warns

    The US Food and Drug Administration (FDA) issued a safety communication Friday to warn about adverse event risks in patients’ use of diabetes management devices lacking approvals or clearances. The safety communication raises the agency’s concerns about whether patients are fully aware of the risks of adverse events when using continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems or components that have not undergone FDA review. FDA e...
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    FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May

    Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and Drug Administration (FDA) held a public workshop on Thursday explaining its goals for the initiative and to discuss ongoing issues related to expanded access.   According to Richard Pazdur, director of FDA’s Oncology Center of Excellence, the pilot will be rolled out towards the end of May.   “Access to clinical trials and ac...
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    Health Canada Explains Revised Fees for Drugs and Devices

    Following extensive stakeholder engagement, Health Canada announced Thursday its plan to revise the fees paid by pharmaceutical and medical device companies. The plan will be implemented 1 April 2020. Presently, Health Canada recovers 43% of its costs for regulatory activities from industry, while the remaining costs are covered by Canadian taxpayers. But the revised fees will increase that percentage and better align Canada with other jurisdictions, like Australia and ...
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    WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

    The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of antimicrobials. The 24-page document is intended to raise awareness on interpreting relevant GMP guidance sections applicable to managing waste and wastewater from antimicrobials’ production, considering all GMP implementation aspects and focusing on critically important antimicrobials to establish an...
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    Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

    The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials. Among the FDA officials on its scientific leadership board are Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), CDRH’s lead of cybersecurity initiatives, Suzanne S...
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    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
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    BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices

    CareFusion, a subsidiary of Becton Dickinson (BD), agreed to a $3.3 million settlement to resolve allegations of civil fraud under the False Claims Act over purchases and sales of unapproved devices. The case was brought on by the US Department of Justice (DOJ) and alleged that providers who used CareFusion devices in medical procedures submitted false claims to federal insurance programs, such as Medicare. The devices allegedly lacked US Food and Drug Administration ...