All Thumbs Up for OTC Birth Control Pill at FDA Advisory Meeting
In a unanimous vote, advisors to the FDA recommended the agency approve what could become the first-ever over the counter (OTC) birth control pill. All 17 members of the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee said the widespread benefits of switching daily norgestrel tablets 0.075 mg (Opill) […]
FDA Panel Nearly Unanimous on Liver Transplant Perfusion Device
TransMedics’ Organ Care System liver perfusion device got near unanimous support for an indication in liver transplantation by an FDA advisory committee. The agency’s Gastroenterology and Urology Devices Panel voted 14-0 in favor of both efficacy and safety, supporting an indication for the resuscitation, preservation, and assessment of liver allografts from donors after brain death […]