Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn
US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.
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Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.
Agency seeks legislative authority to update outdated generic drug labels when the reference product has been withdrawn.