Friday, January 6, 2012

FDA Issues Draft Social-media Marketing Guidelines

Molly Bernhart Walker, Fierce Government IT, Jan. 4, 2012

From the article: "The Food and Drug Administration issued Dec. 27 draft guidance for pharmaceutical and medical device companies on the use of "emerging electronic media." FDA officials note that the guidance is not comprehensive; rather, it is the first of "multiple planned guidances" on the subject." Read more

See Draft Guidance
Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation Research, Center for Veterinary Medicine, Center for Devices and Radiological Health, December 2011