Publications
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06.05.2017Life Sciences: Product Regulation And Liability In The USAArticles
Lexology
The Food and Drug Administration recently revised its regulations governing submission and approval of new drug applications and abbreviated new drug applications. In the patent space, the America Invents Act provides a streamlined administrative process for challenging the validity of pharmaceutical (and other) patents. Congress also created an abbreviated pathway for biosimilar products, including a regulatory scheme for handling related patent disputes.
Presentations
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11.20.2019Licensing and Commercialization for Life Sciences and Technology CompaniesSpeaking EngagementsSpokane, WA