Strategy-Launch and Pre-Launch Clinical Trials
IBS-Irritable Bowel Syndrome: FDA Approves Amitiza for IBS-C
Only drug available in United States for irritable bowel syndrome with constipation
Date:
04/29/2008
, Publication:
FDA News
, Author:
FDA
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...
Date:
04/22/2008
, Publication:
FDA News
, Author:
FDA
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,
Date:
04/12/2008
, Publication:
St. Pete Times
, Author:
Robert Farley
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
Date:
02/06/2008
, Publication:
MSNBC
, Author:
AP
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...
Date:
02/04/2008
, Publication:
FDA News
, Author:
FDA
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
Date:
01/16/2008
, Publication:
FDA News
, Author:
FDA
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
Date:
09/28/2007
, Publication:
MSNBC
, Author:
Arthur Caplan, Ph.D.
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.
Date:
09/22/2007
, Publication:
MSNBC
, Author:
Associated Press
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
Date:
09/16/2007
, Publication:
MSNBC
, Author:
Carla K. Johnson and Lindsey Tanner Associated Press
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
Date:
08/17/2007
, Publication:
MSNBC
, Author:
Associated Press
http://www.msnbc.msn.com/id/20321830/
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