The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Off-Label

News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance.

Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support.

One concern is that a permissive approach to off-label promotion will decrease incentives to file for approval of new uses.  We’re watching  to see if Wyeth v Levine will provide some new incentives in the opposite direction.

Comments on the new guidance?  Do you think it will survive in the new administration?  Discuss…

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