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    EU committee considers antimicrobial incentives, repurposing oncology drugs

    During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.   The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with atten...
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    Analyses reveal wide variation in PRO measures in cancer trials

    The passage of 21st Century Cures Act in 2015 helped to bolster the inclusion of patient experience data and specifically patient reported outcome (PRO) measures in clinical trials. But even with an increased emphasis on patient reported data, analyses of registrational trials for cancer therapies have shown wide variation in how PRO measures are included and analyzed. A recent analysis of registrational trials for multiple myeloma treatments submitted to the US Food ...
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    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
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    Working group: More guidance needed on MRD in myeloma trials

    A working group formed to consider the use of minimal residual disease (MRD) in the treatment of multiple myeloma and the development of new therapies has issued a call for additional regulatory guidance on the use of MRD as a marker in clinical trials.   The working group, a collaboration of advocacy organizations, patients, research foundations, academic, government agencies and industry, was initially convened in 2016 by the Foundation for the National Institutes of...
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    Analysis: Real-world studies of cancer drugs suffer from poor quality

    Real-world oncology data, which is increasingly being touted as a potential basis for regulatory and reimbursement decisions, tends to be of poor quality and may overstate the survival benefits of cancer drugs, according to a new analysis.   The findings, which were published in the European Journal of Cancer , showed that while most cancer drugs approved in the United States and Europe had some type of real-world data (RWD) study available, the methodological quality...
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    Review: FDA device approval pathways more complex than ever

    The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting.   The findings come from a sweeping study of more than 40 years of medical device regulation by the US Food and Drug Administration (FDA), beginning with the Medical Device Amendments of 1976, which first provided the agency with premarket review authority for devices. The analysis...
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    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...
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    FDA seeks new members for Patient Engagement Collaborative

    The US Food and Drug Administration is seeking eight new members for its Patient Engagement Collaborative (PEC), a group charged with gaining meaningful patient input into medical product development and regulatory decision making.   The 16-member panel includes patients, caregivers, and advocates who serve for 2 to 3 years. The panel is a joint effort between FDA and the Clinical Trials Transformation Initiative . Panel members are expected to participate in two to f...
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    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
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    Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites

    Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients, according to Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner.   “There is real a gap between the makeup of our American public and the representation of our Black community and Black women in clinical trials,” A...
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    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
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    COVID-19, reorg dominated 2020 for FDA Office of New Drugs

    Staff in the U.S. Food and Drug Administration’s Office of New Drugs (OND) began 2020 with a focus on completing the office’s reorganization, but they quickly shifted focus to the global pandemic and supporting accelerated development of new therapeutics to prevent or treat COVID-19, according to the OND’s inaugural annual report.   “Despite the added workload, there were no significant disruptions to OND’s work as staff managed to meet and/or exceed many of the Prescr...