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MACK/FRIST OFF-LABEL BILL WOULD REQUIRE SPONSORS TO PROVIDE "CONCURRENT OR NEW INFORMATION" TO FDA; KASSEBAUM BILL RETURNS TO ORIGINAL APPROACH TO BIOLOGICS

Executive Summary

Manufacturers who disseminate journal articles on off-label uses would be required to alert FDA to all "concurrent or new information" that is published on such uses under an amended off-label dissemination provision prepared by Sens. Mack (R-Fla.) and Frist (R-Tenn.).
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PS027884

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