FDA approves a Medtronic PMA for the CoreValve Evolut PRO valve for treating severe aortic stenosis for symptomatic patients who are at high or extrem...
Two stakeholders say an FDA draft guidance on comparative analyses and related comparative use human factor studies in ANDAs for drug-device combinati...
Sens. Hatch, Grassley, and Cotton ask the Government Accountability Office to determine if drug and biotech companies are abusing FDAs orphan drug pro...
FDA releases a draft guidance on Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.
A federal court jury convicts former New England Compounding Center co-owner Barry Cadden of racketeering and other charges stemming from a 2012 fatal...
PhRMA questions the usefulness of two proposed FDA consumer/healthcare professional studies on deceptive prescription drug advertising.
FDA launches a Web site to support advancement of infectious disease next generation sequencing technology.
Federal Register notice: FDA announces a two-day (4/4-5) public conference entitled FDA CDER Small Business and Industry Assistance (SBIA) Regulatory ...