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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program....
Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.
