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    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
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    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
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    Gottlieb Discusses Efficiencies, Opioids, Pricing and More at National Press Club

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took questions at the National Press Club in Washington, D.C. on Friday, offering perspective on what the agency is doing to be more efficient, actions related to the opioid epidemic and how FDA plays a role in the drug pricing debate. In the question and answer section of the talk, Gottlieb noted the agency will be putting forth more guidelines to drive efficiencies in the development of new therapi...
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    German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies

    Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories. The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its...
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    Report Highlights Cracks in the Market for Generic Competition

    As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages. The analysis, authored by Ernst Berndt and Stephen Murphy of the Massachusetts Institute of Technology, and Rena Conti from the University of Chicago, reveals...
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    FDA Warns Phototherapy Device Maker for Quality System Issues

    The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March. The warning letter, dated 11 July 2017, details eight violations, including validation, recordkeeping and equipment calibration issues. FDA also says the company failed to notify it within 10 days of issuing a recall for one of its devices, and did not do so until the...
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    FDA, NCI to Collaborate Further on Cancer Research

    The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment. "The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technolo...
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    NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

    The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies. The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies. "As genomic sequencing data become mainstream in cancer therapy...
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    International Medical Device Regulatory Update: News and Views From San Jose

    Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medica...
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    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
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    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...
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    EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

    The European Medicines Agency (EMA) on Thursday released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across international regulatory efforts. EMA says the report was developed on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA) to "provide a general overview of multi-project initiatives in which multiple regulators were involved." Backgro...