dc.contributor.advisor | Peter Hutt | en_US |
dc.contributor.author | Foster, Suzanne | |
dc.date.accessioned | 2012-05-19T21:56:02Z | |
dc.date.issued | 2009 | |
dc.identifier.citation | Suzanne Foster, FDA’s Position on Off-Label Use and Promotion of Drugs and Devices and
Recent Enforcement Efforts by the Department of Justice (April 2009). | en_US |
dc.identifier.uri | http://nrs.harvard.edu/urn-3:HUL.InstRepos:8789612 | |
dc.description.abstract | Off-label drug or medical device “use” is the practice of prescribing drugs or medical devices to patients for a purpose not included on the federally approved label. Off-label “marketing” is the practice of attempting to influence physicians to prescribe drugs or devices for off-label purposes. The Federal Food and Drug Administration (FDA) maintains regulatory authority over the proper labeling of drugs and medical devices. This paper summarizes the FDA’s position on off-label use, promotion, and marketing and provides a summary of recent enforcement actions by the U.S. Department of Justice regarding off-label marketing. | en_US |
dash.license | LAA | |
dc.subject | human drugs>>prescription drug promotion>>information on unapproved uses | en_US |
dc.subject.other | Food and Drug Law | en_US |
dc.title | FDA’s Position on Off-Label Use and Promotion of Drugs and Devices and Recent Enforcement Efforts by the Department of Justice | en_US |
dc.type | Paper (for course/seminar/workshop) | en_US |
dc.date.available | 2012-05-19T21:56:02Z | |