FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis who are at low risk f...
FDA issues a guidance to help drug sponsors design nonclinical bone studies to support approval of drugs and biologics intended to treat osteoporosis.
FDA says it is working in several ways with manufacturers to try to mitigate the current shortage of immune globulin products.
FDA says Pfizer has recalled two lots of its migraine drug Relpax because they may not meet the company microbiological specification for the potentia...
FDA grants V-Wave a breakthrough device designation for its interatrial shunt for heart failure.
FDA describes updates it will make to the inactive ingredient database as required under GDUFA 2.
A New York Times editorial suggests three steps to address problems arising in expedited drug approvals, including extremely high patient costs.
Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CFR 801...