Skip to main content
FDA issues guidance on value-based drug contracts, off-label comms

New FDA guidance covers drugmakers' communications with payers, including insurance companies and formulary committees, on the safety, efficacy and cost-effectiveness of approved medical products. A second guidance document explains the agency's views on the communication of information not on drug labels, such as data from pre- or post-market studies and surveillance that might help guide patient care.

Full Story: