Search Results - "Herder, Matthew"

What Is the Purpose of the Orphan Drug Act? by Herder, Matthew

“…Matthew Herder suggests it may be time to re-examine the purpose of the U.S. Orphan Drug Act…”
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'More of the same, but worse than before': A qualitative study of the challenges encountered by people who use drugs in Nova Scotia, Canada during COVID-19 by Comeau, Emilie, Bonn, Matthew, Wildeman, Sheila, Herder, Matthew

“…To learn about the experiences of people who use drugs, specifically opioids, in the Halifax Regional Municipality (HRM), in Nova Scotia, Canada during the…”
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High-strength opioid formulations: the case for a ministerial recall by Herder, Matthew, JSM LLM, Juurlink, David, MD PhD

“…Until recently, the power to recall pharmaceuticals from the market was absent from Canadian law. In November 2014, this deficiency was remedied with the…”
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Exploring the Food and Drug Administration’s review and approval of Entresto (sacubitril/valsartan) by Eadie, Ashley L., Brunt, Keith R., Herder, Matthew

“…Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and…”
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Biopharmaceutical Financialization and Public Funding of Medical Countermeasures (MCMs) in Canada During the COVID-19 Pandemic by Eren Vural, Ipek, Herder, Matthew, Doll, Agnieszka, Graham, Janice E

“…Analysing the Canadian government's efforts to support the development of COVID-19 "medical countermeasures" (MCMs), this article seeks insights into political…”
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Protecting expert advice for the public: promoting safety and improved communications by Wright, Julia M., Chun, Wendy Hui Kyong, Clarke, Amanda, Herder, Matthew, Ramos, Howard

“…The drivers of the harassment and intimidation of researchers are complex, widespread, and global in their reach and were being studied across many disciplines…”
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Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency by HERDER, MATTHEW

“…Policy Points The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and…”
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Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform by Herder, Matthew

“…The US Food and Drug Administration's controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer's disease, has…”
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Clinical trial registration and results reporting: a call for transparency, coordination, and meaningful enforcement by Herder, Matthew, Murthy, Srinivas

“…Trial registration and timely reporting are critical safeguards against data manipulation, cherry-picking of results, and persisting biases in favor of…”
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Demythologizing PHOSITA- applying the non- obviousness requirement under Canadian patent law to keep knowledge in the public domain and foster innovation by Herder, Matthew

“…The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical "selection patent" case, Apotex Inc. v. Sanofi-Synthelabo…”
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Reinstitutionalizing transparency at Health Canada by Herder, Matthew

“…Parliament's passage of Bill C-17, "Vanessa's Law," in 2014 may finally mark the beginning of change. Inspired by the death of MP Terence Young's daughter,…”
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Government regulators must steward drug transparency by Herder, Matthew

“…The pharmaceutical industry has recently taken steps to make clinical trial data more accessible. But for there to be meaningful transparency, governments—not…”
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'Our project, your problem?' A case study of the WHO's mRNA technology transfer programme in South Africa by Herder, Matthew, Benavides, Ximena

“…In June 2021 the World Health Organization (WHO) and the Medicines Patent Pool (MPP) launched an mRNA technology transfer programme. With a South African…”
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Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results by Herder, Matthew

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Enregistrement des essais cliniques et production de rapports sur les résultats: un appel à la transparence, à la coordination et à une application rigoureuse des règles by Herder, Matthew, Murthy, Srinivas

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Pharmacare Act does not prescribe universal, public pharmacare by Morgan, Steven G, Herder, Matthew

“…Morgan and Herder criticize the Pharmacare Act, Bill C-64. The legislation promises to provide immediate coverage of contraceptives and diabetes medications,…”
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A responsibility to commercialize? Tracing academic researchers' evolving engagement with the commercialization of biomedical research by Holloway, Kelly, Herder, Matthew

“…Governments and academic institutions have embraced the importance of commercializing research through the late twentieth century. In this study, we seek to…”
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Canada finally opens up data on new drugs and devices by Lexchin, Joel, Herder, Matthew, Doshi, Peter

“…Other regulators should take note of Health Canada’s substantive reforms…”
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When Everyone Is an Orphan: Against Adopting a U.S.-Styled Orphan Drug Policy in Canada by Herder, Matthew

“…Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in…”
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Toward a Jurisprudence of Drug Regulation by Herder, Matthew

“…Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical…”
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