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Biotech / Medical : Ligand (LGND) Breakout!
LGND 203.18-1.4%Nov 28 9:30 AM EST

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To: Henry Niman who wrote (27958)2/7/1999 7:52:00 PM
From: RXGOLF  Read Replies (1) of 32384
 
<<Greg, I have known about the peer review requirement for off-label use and for some reason assumed that this was regarding peer-reviewed papers of clinical trials.

However, I'm not that sure about the content of the reports. Can pre-clinical data also be distributed? Thus, when Targretin oral is approved for CTCL, can reps give out peer reviewed publications on prevention and treatment of type II diabetes and breast cancer in animal models?>>

Sorry it has taken so long to post, had to get 18 holes in :- ).

The info on unlabeled uses must meet certain restrictions, and some are:
They can only give written info, not discuss the off label use.
The off-label uses must come from peer-reviewed, scientific or medical journals. The reps can not hand out letters to the editor,abstracts, or drug company-funded supplements.
Articles must be identified with a special sticker if they are about an off label use.

IMO if pre-clinical data was taken from a scientific journal, it could then be handed to the Dr.

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