FDA Drug Center Includes Off-Label Guidance On Its 2016 Agenda

The FDA drug center's 2016 guidance agenda, unveiled Friday (Jan. 22), includes several long-promised documents related to the off-label promotion of approved drugs. The agenda comes as agency officials debate how to proceed on the controversial off-label topic and review legal issues surrounding FDA policies on the issue. The drug center's guidance agenda lists the following off-label documents: Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration...