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FDA regulation related Press Releases

California Healthcare Institute Board Elects New Member

Posted November 7, 2011

LA JOLLA, Calif.--(BUSINESS WIRE)-- CHI-California Healthcare Institute announced today the election of Rick Winningham, who serves as CEO of South San Francisco-based Theravance, to serve on the CHI Read more...

FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene

Posted July 8, 2009

FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain Read more...

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

Posted July 1, 2009

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 Read more...

Merck Statement in Response to FDA's June Communication with Updated Information on Leukotriene Inhibitors, Including Singulair

Posted June 15, 2009

Merck Statement in Response to the FDA's June 12, 2009 Communication with Updated Information on Leukotriene Inhibitors, Including SINGULAIR® (montelukast sodium) WHITEHOUSE STATION, Read more...

FDA Requests Labeling Change for Leukotriene Modifiers

Posted June 15, 2009

FDA Requests Labeling Change for Leukotriene Modifiers The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene Read more...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma a

Posted May 19, 2009

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin Read more...

Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

Posted May 14, 2009

Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial CALGARY, ALBERTA--(Marketwire - May 14, 2009) - Stem Cell Therapeutics Corp. ("SCT" or "the Read more...

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

Posted April 28, 2009

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely The Food and Drug Administration issued a final rule today that requires

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FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

Posted April 28, 2009

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans The U.S. Food and Drug Administration, in response to requests from the U.S. Centers

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