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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FDA recommends sponsors take the breakpoint information out of the labels for their approved antimicrobial products, and instead include a link to agency's newly launched website with breakpoint data.
Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.
FDA must place antimicrobial breakpoints that usually appear in labeling on a website so they can be more regularly updated. CDER Director Woodcock said that could become a precedent for other electronic labeling changes.