Insert information, says PhRMA, may not be up-to-date, especially for drugs with frequent labeling changes. The goal of the Task Force is to add an option for an electronic “package insert” rather than the paper insert requirement.
FDA’s Center for Drug Evaluation and Research is making available on its Intranet 8 ½”x11”, 12-pt versions of approved professional labeling for all CDER reviewers. The Task Force proposes that the initiative be expanded to a system that allows the manufacturer the option to use full prescribing information in lieu of paper for all purposes.
