FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clar...
Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communications.
FDA sends Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal syndrome Type 1.
Federal Register notice: FDA requests that stakeholders notify it about their intent to participate in periodic consultation meetings on reauthorizing...
FDA posts a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.
FDA posts an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a question-bas...
Becton Dickinson CareFusion 303 recalls its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery scre...
Federal Register notice: FDA corrects a 9/2 Federal Register notice that announced the availability of drug post-marketing pediatric-focused safety re...