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Latest FDA News and Information
FDA Announces New Boxed Warning on Plavix
The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be... read more
FDA Task Force Seeks Public Comments on Increasing Transparency with Regulated Industry
As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the... read more
FDA Issues Warning on Counterfeit Surgical Mesh
The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol... read more
FDA March 11 Update on the Investigation into the Salmonella Montevideo Outbreak
March 11 Update - 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... read more
Food and Drug Adminstration (FDA): CDRHNew
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Class I Medical Device Recall: Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
These sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall (septum).
Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication
FDAapos;s and Bardapos;s investigations show that the counterfeit product is labeled with the following product codes, sizes and lots of Bard Flat Mesh. To date four product sizes... read more
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.
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
