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Latest FDA News and Information
FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common... read more
FDA Update on the Investigation into the Salmonella Montevideo Outbreak - March 5, 2010
As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag,... read more
FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors
The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev.... read more
FDA Approves Name Change for Heartburn Drug Kapidex
The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole)... read more
Food and Drug Adminstration (FDA): CDRHNew
Class I Medical Device Recall: Abiomed, Inc., AB5000 Circulatory Support System
Reason for Recall: The computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.
Class I Medical Device Recall: Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell
These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a... read more
Class I Medical Device Recall: Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)
These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device?s Daily/Weekly/Monthly self-tests. These defects can... read more
510(k) Final Decisions - February 2010
What's New: Vaccines, Blood Biologics RSS Feed
Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Vaccine lot release information updated on 3/3/2010.
DIA/FDA CDER/CBER Computational Science Annual Meeting
This meeting will review progress on topics such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools.
Hizentra
Cord Blood Licensure: A Workshop
March 8 - 9, 2010
