Chain drug stores urge FDA to withdraw a draft guidance on waivers for single, shared system REMS, and other stakeholders also critique it.
An online CDER post describes work of Center statistical researchers in developing complex innovative clinical trial designs.
FDA commissioner Scott Gottlieb says the agency is modernizing its approach to medical product regulation to support innovation in development of drug...
The New Jersey federal court approves a permanent injunction sought by FDA against several companies and their executives charged with illegally selli...
FDA approves Auris Medicals proposed choice of primary and secondary efficacy endpoints for a pivotal Phase 3 trial of AM-111 (brimapitide), an invest...
FDA approves two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs Delstrigo and Pifeltro.
Three House members introduce legislation to create a prescription drug safety alert system to give drug dispensers patient information that can help ...
Researchers say FDA should issue time-limited breakthrough device approvals with mandated period review of a devices safety and effectiveness to be su...