An FDA letter to healthcare professionals warns about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohe...
FDA sends Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, a cardiac myosin activator for treating heart failure with reduce...
Federal Register notice: FDA withdraws approval of 11 ANDAs because the drug products are no longer marketed.
CBER issues four Standard Operating Policy and Procedure documents for staff handling of four types of CBER-regulated product submissions.
FDA issues an import alert to restrict the unlawful importation of the veterinary drug xylazine that has been found in illicit fentanyl and other drug...
FDA releases a summary of a 2020 workshop held with the Federal Trade Commission on a competitive marketplace for biosimilars.
FDA commissioner Robert Califf updates several activities that are part of his vision for restructuring the Office of Regulatory Affairs and the agenc...
Universities Allied for Essential Medicines is calling on FDA to step up enforcement of the clinical trial reporting requirements in the 2007 FDA Amen...
