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Latest FDA News and Information
FDA Approves Multaq to Treat Heart Rhythm Disorder
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart... read more
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline)... read more
FDA Seeks Public Input on Tobacco Regulation
The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States.... read more
FDA Confirms E. Coli O157:H7 in Prepackaged Nestlé Toll House Refrigerated Cookie Dough
Today, the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of... read more
Food and Drug Adminstration (FDA): CDRHNew
CDRH White Oak Move (Updated)
The Center for Devices and Radiological Health (CDRH) will be relocating to the FDA White Oak campus located at 10903 New Hampshire Avenue, Silver Spring, MD 20993 this summer.
Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities, September 14-16, 2009
The CDRH Forum is established for the exchange of medical device regulatory information between the USFDA CDRH and its counterpart agencies in other countries. The training is limited to international... read more
Summary Information for: Cervistaamp;trade; HPV 16/18
Labeling, Approval Order, and Summary of Safety and Effectiveness for Cervistaamp;trade; HPV 16/18 (P080015).
Summary Information for: Cervista? HPV HR and Genfind? DNA Extraction Kit
Labeling, Approval Order, and Summary of Safety and Effectiveness for CervistaTM HPV HR and GenfindTM DNA Extraction Kit (P080014).
