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September 24, 2008

Off-Label Indications for Medication Use and the Published Literature

JAMA. 2008;300(12):1411-1412. doi:10.1001/jama.300.12.1411-b

To the Editor: In their Commentary criticizing the guidelines proposed by the Food and Drug Administration (FDA) on off-label promotion, Drs Psaty and Ray1 point to shortcomings in the peer-reviewed literature about unapproved uses of approved drugs and devices. However, in focusing on sponsors' distribution of such literature, the authors fail to recognize the full extent of the problem.

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