Public Citizen and PhRMA air their disagreement over an FDA proposal to use integrated review documents in communications about new drug approvals.
FDA clears a 4Web Medical 510(k) to market its Cervical Spine Truss System-Stand Alone interbody fusion device.
Five stakeholders offer supporting comments on an FDA draft guidance on endpoints for developing drugs to treat heart failure.
Federal Register notice: FDA reopens the comment period for a 3/1 notice on international drug scheduling for Dronabinol.
FDA clears a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and...
FDA releases a final guidance on use of placebos and blinding in cancer clinical trials.
FDA accepts for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients with neuromyelitis opt...
FDA issues a safety alert on three chronic hepatitis drugs after some patients with moderate to severe liver impairment experienced worsening liver fu...