Chartex claims its rights to WPC's female condom PMA extend to FHI data.
This article was originally published in The Gray Sheet
Executive SummaryCHARTEX RIGHTS TO WISCONSIN PHARMACAL FEMALE CONDOM PMA include the data gathered by Family Health International and referenced by Wisconsin Pharmacal in its premarket approval application approved in May 1993, Chartex says in a Nov. 13 letter to FDA. The Chartex letter responds to Wisconsin Pharmacal's challenge to the approval of Chartex' Femidom female condom, which was granted based on the WPC/FHI data ("The Gray Sheet" Aug. 21, p. 29).
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