Finnegan partner Bryan Diner will co-present "Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry" at American Conference Institute's 35th annual FDA Boot Camp. For more information, or to register, please see ACI's website.
Tags
505(b)(2) application, Biologics Price Competition and Innovation Act (BPCIA), drugs, duty to disclose, Food and Drug Administration (FDA), new drug application (NDA), Orange Book, patent exclusivity, patent reform, patent term extension
