This article was originally published in The Gray Sheet
Executive SummaryFDA 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).
You may also be interested in...
OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.
Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.
Recommendations from the Alliance for Regenerative Medicine aim to improve cross-border healthcare to ensure patients can access advanced therapies.