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Five stakeholders offer supporting comments on an FDA draft guidance on endpoints for developing drugs to treat heart failure.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 its latest batch of Warning Letters that includes CTX Lifesciences and Ningbo Pulisi Daily Chemical Products.
Attorney Anne Walsh says regulated companies may cite a recent Supreme Court decision when challenging the notion of judicial deference to FDAs interp...
Federal Register notice: FDA makes available a draft guidance entitled Male Breast Cancer: Developing Drugs for Treatment.