Late last year, the FDA released its draft “Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” This is the first of multiple planned draft guidances responding to testimony and comments from 2009 hearings addressing social media marketing by manufacturers and distributors of prescription drug products and medical devices.
This first draft guidance recommends how companies should respond to unsolicited requests for off-label information about their drugs and devices, including requests received through ...