Headlines

Latest FDA News and Information

FDA Approves New Formulation of Coagulation Therapy

he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The... read more

FDA Approves First Generic Ropinirole

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products

The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.

Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction

Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by... read more

FDA Center for Drug Evaluation and Research - What's New

CDER Organization Charts

CDER Organization Charts (updated)

Drug Safety Oversight Board Meeting Public Summary

Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary

Drug Shortage: Digitek (digoxin tablets, USP)

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed... read more

FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed

FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available... read more

Food and Drug Adminstration (FDA): CDRHNew

Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts

On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography (... read more

Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides

On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT?). The IMT?, a visual... read more