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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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
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creator Kitchens, William H
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description 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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ispartof The National Law Journal, 1998-08, Vol.21 (1), p.B5
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source Nexis UK
subjects Bans
Federal legislation
Information dissemination
Pharmaceutical industry
Regulatory agencies
title FDA regime for off-label use emerges
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