FDA is considering proactive communication of early adverse event reports from its MedWatch monitoring system as the agency reassesses its proposed Drug Watch website for emerging safety information

FDA is unlikely to proceed with developing a follow-on biologics pathway until a permanent commissioner is confirmed, a Senate Health Committee staffer said at a Food & Drug Law Institute conference in Washington, D.C., Nov. 16

Offering extended exclusivity, in advance, for drugs that address an unmet medical need could bring a necessary boost to research and development efforts, Vanderbilt University's Alastair Wood said