FDA regime for off-label use emerges

The FDA has proposed regulations to implement legislation ending a ban on manufacturers' dissemination of off-label use information. The 1997 FDA Modernization Act's provisions are examined.

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Bibliographic Details
Published in:The National Law Journal 1998-08, Vol.21 (1), p.B5
Main Authors: Kitchens, William H, Minsk, Alan G
Format: Article
Language:English
Subjects:
Bans
Federal legislation
Information dissemination
Pharmaceutical industry
Regulatory agencies
Online Access:Get full text
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Description
Summary:The FDA has proposed regulations to implement legislation ending a ban on manufacturers' dissemination of off-label use information. The 1997 FDA Modernization Act's provisions are examined.
ISSN:2163-8756