FDA advises health care professionals not to use BioDiagnostics Internationals Monsels Solution (ferric subsulfate 20%) because the drug product was m...
In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 9.
Federal Register notice: FDA makes available a draft guidance entitled Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Rec...
FDA issues a draft guidance on designing nonclinical programs for developing oncology radiopharmaceuticals.
FDA issues a guidance explaining Biosimilar User Fee Amendment changes made in the 2017 program reauthorization.
FDA releases information on two new drug quality metrics feedback programs.
FDA grants Rafael Pharmaceuticals an orphan drug designation for CPI-613, an altered energy metabolism directed drug candidate for treating Burkitt Ly...
Federal Register notice: FDA announces an 8/22 public workshop entitled Development of Non-Traditional Therapies for Bacterial Infections.