FDA says it is working with the National Institutes of Health and the European Medicines Agency on a global substance registration system.
FDA commissioner Robert Califf says FDA and its state and federal partners have made great progress in oversight of drug compounding, but there are st...
FDA posts updated definitions of face-to-face meeting formats to the PDUFA 7 and BsUFA 3 Web pages.
Federal Register notice: FDA makes available a final guidance entitled Cross Labeling Oncology Drugs in Combination Regimens.
Federal Register notice: FDA requests comments on the topics discussed at its 9/14 public workshop entitled Advancing Premarket Safety Analytics Works...
Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.
FDA publishes a guidance on cross-labeling of oncology drugs used in combination regimens.
FDA says the Teleflex recall of 60,000 Iso-Gard Filter S units is Class 1.
