FDA Related News

Medical Devices

Cook Medical Recalls Zenith Endovascular Graft

Cook Medical recalls its Zenith Alpha Thoracic Endovascular Graft when used for treating blunt traumatic aortic injury because blood clots may form in...

Califf Wants Sweeping Overhaul of Clinical Trial System

Former FDA commissioner Robert Califf calls for a federated system generating fundamental data needed for a new approach to balancing safety and speed...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Foshan Flying Medical Products Co. and Homeolab USA.

Medical Devices

FDA OKs MobiusHD CALM 2 Trial

FDA approves Vascular Dynamics IDE application for the CALM 2 pivotal trial of its MobiusHD system to treat resistant hypertension.

Medical Devices

BioStable Aortic Annuloplasty Device Cleared

FDA clears a BioStable Science & Engineering 510(k) for the HAART 200 Aortic Annuloplasty Device, an annuloplasty device designed specifically for bic...

Human Drugs

Transcript Posted on FDA Hatch-Waxman Amendments

FDA posts a transcript of a 7/19 public meeting on Hatch-Waxman Amendments and its discussion on whether an appropriate balance is still maintained be...

Human Drugs

FDA Accepts Portola Pharmaceuticals BLA Resubmission

FDA accepts for review a Portola Pharmaceuticals BLA resubmission for AndexXa (andexanet alfa) and its use as a universal reversal agent for patients ...

Human Drugs

CGMP Issues at Chinas Foshan Flying Medical

FDA warns Chinas Foshan Flying Medical Products about CGMP violations in producing finished pharmaceuticals.

Human Drugs

Homeolab Inspection CGMP Violations

FDA warns Canadas Homeolab USA about CGMP violations in its manufacturing of finished pharmaceuticals.

Human Drugs

FDA Clears Camber Spines Interbody Fusion Implant

FDA clears a Camber Spine Technologies 510(k) for the SPIRA Open Matrix ALIF device, an interbody fusion implant.