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SNDA approvals, off-label dissemination to be subjects of Rep. Shays oversight hearing Sept. 12.

Executive Summary

SUPPLEMENTAL NDA APPROVALS HOUSE OVERSIGHT HEARING TO FEATURE GAO REPORT, recently updated, on the prevalence of off-label uses. The General Accounting Office estimates that "80%-100% of cancer, pediatric and rare disease patients are using off-label drugs," Rep. Shays (R-Conn.) announced Sept. 5. The full report, which updates a 1991 GAO study, will be released Sept. 12 at a hearing on supplemental NDAs held by Shays' House Government Reform/Human Resources Subcommittee.
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