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Adapting Federal Regulatory Approaches To Advances In Agricultural Biotechnology, Alan Sachs

Maryland Law Review Online

No abstract provided.

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

Articles, Book Chapters, & Popular Press

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

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Immoral Patents, David O. Taylor

Faculty Journal Articles and Book Chapters

Only to a limited extent have U.S. legislators recognized the moral and ethical implications of the patentability of controversial technologies. I find this absence of legislative debate curious for several reasons, including the fact that for decades there has been an intense public debate over the government’s involvement in, and regulation of, research and development related to biotechnology, including reproduction technologies, and particularly the use and destruction of embryonic stem cells, embryos, and fetuses—areas of considerable moral and ethical concern. Nor has there been debate regarding patentability with respect to other areas of concern, such as technologies that damage the …