FDA approves Biotroniks Acticor and Rivacor high-voltage cardiac rhythm management device lines for treating patients with cardiac arrhythmias.
FDA approves a new indication for Abbott Vasculars MitraClip mitral valve clip delivery system.
FDA commissioner Scott Gottlieb says several new guidances are intended to prod sponsors and clinical research organizations to modernize the clinical...
FDA approves a BD (Becton Dickinson) PMA for the Venovo venous stent, indicated for treating iliofemoral venous occlusive disease.
The Justice Department says five individuals and two companies are pleading guilty to fraudulently marketing two workout and weight loss dietary suppl...
Healthcare communications consultant Mark Senak says the CDER Office of Prescription Drug Promotion is showing an enforcement focus on promotion of un...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients....
FDA releases the FDA-483 with 10 observations from an inspection at the Genetech umbilical cord processing facility.