FDA issues a safety alert on three chronic hepatitis drugs after some patients with moderate to severe liver impairment experienced worsening liver fu...
FDA explains new requirements that are part of an upcoming switch to FAERS II that uses changes agreed to in an International Council for Harmonizatio...
CDER director Janet Woodcock and CBER director Peter Marks use an FDA Voices post to defend increases in the use of five congressionally mandated expe...
CDER director Janet Woodcock says the number of people actually exposed to contaminated angiotensin I receptor blockers is likely lower than the numbe...
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Five stakeholders offer supporting comments on an FDA draft guidance on endpoints for developing drugs to treat heart failure.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.