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Strategy-Launch and Pre-Launch Clinical Trials


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IBS-Irritable Bowel Syndrome: FDA Approves Amitiza for IBS-C

Only drug available in United States for irritable bowel syndrome with constipation
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html

Crohn's Disease: FDA Approves Cimzia to Treat Crohn's Disease

Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies...
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html

Drug research: To test or to tout?

In the 1990s, drug companies trumpeted a new class of drugs, atypical antipsychotics,
http://www.tampabay.com/news/health/article454391.ece

Major diabetes trial halted after deaths

257 patients died after intense therapy to lower blood sugar, NIH reports
http://www.msnbc.msn.com/id/23029191/

President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports

The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs...
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html

FDA Issues Documents on the Safety of Food from Animal Clones

Agency Concludes that Meat and Milk from Clones of Cattle, Swine, and Goats, and the Offspring of All Clones, are as Safe to Eat as Food from Conventionally Bred Animals
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01776.html

Report paints grim picture of drug trial safety

Criticism of FDA's weak oversight are on target, but Congress shares blame
http://www.msnbc.msn.com/id/21029879/

New AIDS Vaccine Fails to Work, Major Study Halted

TRENTON, N.J. — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study.
http://www.foxnews.com/story/0,2933,297697,00.html

Woman's death calls gene therapy into question

Jolee Mohr died three weeks after experimental treatment using a virus
http://www.msnbc.msn.com/id/20730647/

FDA is rejecting more new drugs than in past

Agency is 'more cautious' in wake of Vioxx problems, expert says
http://www.msnbc.msn.com/id/20321830/
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Search returned 177 items.
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