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Expert Analysis

FDA Opens Useful Dialogue On Orange Book Patent Listings

By Jonathan Davies, Jason Lief and Sanya Sukduang ( June 18, 2020, 6:48 PM EDT) -- In a notice published in the Federal Register on June 1 concerning the establishment of a public docket via patent information listing in the Orange Book, the U.S. Food and Drug Administration has asked for public comment on the long-standing question as to what types of pharmaceutical patents should be listed in the FDA's Orange Book and "the impact that any change to current patent listing practices may have on drug product development."[1]...

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