美国食品药品监督管理局的“从头开始”医疗器械审批途径、专利与反竞争行为 - Suppr

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超能文献

The FDA De Novo medical device pathway, patents and anticompetition.

作者信息

Sherkow Jacob S, Aboy Mateo

机构信息

College of Law, University of Illinois at Urbana-Champaign, Champaign, IL, USA.

Carl R. Woese Institute for Genomic Biology, University of Illinois at Urbana-Champaign, Champaign, IL, USA.

出版信息

Nat Biotechnol. 2020 Sep;38(9):1028-1029. doi: 10.1038/s41587-020-0653-6.

DOI:10.1038/s41587-020-0653-6

PMID:32887962

Abstract

摘要

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The FDA De Novo medical device pathway, patents and anticompetition.美国食品药品监督管理局的“从头开始”医疗器械审批途径、专利与反竞争行为

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Clarification: 510k is premarket notification; it provides no patent or FDA approval.说明：510k是上市前通知；它不提供专利或FDA批准。

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If it's regulated like a duck ... uncertainties in implementing the patent exceptions of the Drug Price Competition and Patent Term Restoration Act.如果它像鸭子一样受到监管……《药品价格竞争与专利期限恢复法案》专利例外实施中的不确定性。

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Should patenting of surgical procedures and other medical techniques by physicians be banned?医生对外科手术及其他医疗技术申请专利是否应被禁止？

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FDA pilot programme in support of global harmonisation.美国食品药品监督管理局支持全球协调的试点项目。

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Bilski blundering biotech.比尔兹利，蹩脚的生物技术公司。

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Research use exemptions to patent infringement for drug discovery and development in the United States.美国药物研发中专利侵权的研究用途豁免。

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Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway.超越510(k)：新型中度风险医疗器械的监管、知识产权考量以及美国食品药品监督管理局（FDA）“重新分类”途径中的创新激励措施

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