Saturday, September 13, 2008

The U.S. Food and Drug Administration


New Information on Drug?s Label
New York Times Fri, 12 Sep 2008 9:25 PM PDT
The Food and Drug Administration has updated the label of Merck?s cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers.

Warning on Chinese Baby Formula
New York Times Fri, 12 Sep 2008 9:25 PM PDT
Chinese infant formula sold illegally in ethnic markets in the United States may be tainted with the chemical melamine, the Food and Drug Administration warned.

FDA approves vulvar, vaginal cancer vaccine
USA Today Fri, 12 Sep 2008 3:50 PM PDT
The Food and Drug Administration on Friday approved Merck's Gardasil vaccine to prevent vulvar and vaginal cancers. Gardasil was originally approved in 2006 to prevent infection with four strains of the human papillomavirus, or HPV, that cause most genital warts and cervical cancers.

Merck vaccine wins OK for vaginal cancer
Reuters via Yahoo! News Fri, 12 Sep 2008 3:40 PM PDT
U.S. health regulators have approved Merck and Co's Gardasil vaccine to protect women against rare vaginal and vulvar cancers, the Food and Drug Administration said on Friday.

Treatment for Rare Neurologic Disease Approved
Kansas City InfoZine Sat, 13 Sep 2008 8:24 AM PDT
The U.S. Food and Drug Administration announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

FDA expands uses of cancer vaccine
UPI Fri, 12 Sep 2008 7:26 PM PDT
WASHINGTON, Sept. 12 (UPI) -- The U.S. Food and Drug Administration has expanded the use of the cervical vaccine Gardasil for the prevention of vaginal and vulvar cancers.

FDA warns against Chinese infant formula
UPI Fri, 12 Sep 2008 10:56 AM PDT
WASHINGTON, Sept. 12 (UPI) -- The U.S. Food and Drug Administration said no infant formula made in China has been approved for import into the United States.

US FDA grants fast track status for Proteon's drug
PharmaBiz Sat, 13 Sep 2008 3:52 AM PDT
Proteon Therapeutics, Inc has received US Food and Drug Administration (FDA) fast track designation for the development programme for PRT-201. PRT-201 is being investigated for its ability to improve vascular access in patients currently on or being prepared for haemodialysis.

Gardasil Approved Against More Cancers
WHSV Harrisonburg Fri, 12 Sep 2008 9:36 PM PDT
The Food and Drug Administration announced Friday the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV).

Few safeguards for Mexican produce heading north
The Charlotte Observer Sat, 13 Sep 2008 6:41 AM PDT
At the end of a dirt road in northern Mexico, the conveyer belts processing hundreds of tons of vegetables a year for U.S. and Mexican markets are open to the elements, protected only by a corrugated metal roof. The U.S. Food and Drug Administration suspects this packing plant, its warehouse in McAllen, Texas, and a farm in Mexico are among the sources of the United States' largest outbreak of ...




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