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Software Biologics

Venable LLP

AI On the Prize: Decoding FDA's Latest Guidance

Venable LLP on

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

Robinson+Cole Manufacturing Law Blog

Manufacturers are Not Immune to Claims that their Inventions are Patent-Ineligible

It is no secret that the competitive edge of U.S.-based manufacturers is often predicated, at least in large part, on technological innovation and the patents that protect them. The broader the patents, the better. Usually...more

McDermott Will & Emery

FDA 2016 Year in Review

McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

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