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...
FDA posts PDUFA 7 updates to the model-informed drug development paired meeting program.
GSK stops enrollment early due to positive results two Phase 3 trials evaluating gepotidacin, an investigational drug for uncomplicated urinary tract ...
FDA says it is working with the National Institutes of Health and the European Medicines Agency on a global substance registration system.
Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program....
