Mentor preparing silicone breast implant Phase III study protocol.
This article was originally published in The Gray Sheet
Executive SummaryMENTOR SILICONE BREAST IMPLANT PHASE III PROTOCOL SUBMISSION TO FDA could occur as early as September, according to the com-pany. While final details of the protocol have not been worked out, Mentor says the clinical trial will involve a small number of investigators and several hundred women who have never had breast implants. The trial -- the third and final phase of a study called for by FDA in 1992 -- will include both reconstruction and augmentation procedures.
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.