Wisconsin Pharmacal
This article was originally published in The Gray Sheet
Executive Summary
FDA completes its preapproval inspection of the firm's Reality female condom manufacturing plant, the firm reports. In addition, the agency "has initiated labeling discussions" with Wisconsin Pharmacal regarding the product. In December, FDA's obstetrics and gynecology devices panel recommended that the device be approved subject to labeling modifications ("The Gray Sheet" Dec. 14, p. 20).