Antimicrobial Sponsors Should Update Labels Within Year Of Breakpoint Webpage Launch, US FDA Says
Executive Summary
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.
You may also be interested in...
House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule
Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.
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.
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.