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Article: Proposed FDA Rule Relaxes Use of Off-Label Articles.(United States. Food and Drug Administration)
- Article from:
- BIOWORLD Today
- Article date:
- February 20, 2008
- Author:
CopyrightCOPYRIGHT 2008 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Donna Young, Washington Editor
The FDA is considering permitting drug and device makers to more broadly use published scientific and medical journal articles about unapproved, or off-label, uses when promoting their FDA-approved products to physicians.
While physicians are free to prescribe drugs and devices for off-label uses, manufacturers are banned from promoting their products for indications not approved by the FDA. However, the agency in a new draft guidance document issued Friday, proposed that firms under certain circumstances may distribute journal articles and other publications about the off-label uses of approved products.
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