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FDA Opens Useful Dialogue on Orange Book Patent Listings

Law360

"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 US 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.'"

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Related Contacts
Jonathan Davies  Partner Washington, DC
Sanya Sukduang  Partner Washington, DC