FDA and academic researchers present a framework to include transgender people in clinical trials.
FDA issues a safety alert warning parents and caregivers not to use infant head shaping pillows intended to change an infants head shape or symmetry. ...
FDAs Pharmaceutical Science and Clinical Pharmacology Advisory Committee unanimously votes to recommend that CDER move forward with developing and imp...
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.
