food and drug administration

The MDS Foundation supports the FDA's decision to expand vidaza ...

admin — Mon, 25 Aug 2008 00:00:00 -0500

(Weber Shandwick Worldwide) The Myelodysplastic Syndromes Foundation supports the decision by the US Food and Drug Administration to extend the label for vidaza to include data from the AZA-001 clinical trial. Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

FDA to Revise Rules For Cold Medications Meant for Children

admin — Sat, 23 Aug 2008 00:00:00 -0500

The Food and Drug Administration yesterday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market.

FDA Allows Irradiation of Some Produce

admin — Fri, 22 Aug 2008 00:00:00 -0500

Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce because of a new Food and Drug Administration ruling meant to help head off outbreaks of foodborne illness.

FDA approves Vidaza label expansion

admin — Thu, 21 Aug 2008 00:00:00 -0500

(Weber Shandwick Worldwide) The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the US Food and Drug Administration has expanded the label for Vidaza (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients. Vidaza was also shown to delay progression to acute myelogenous leukemia in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

ADVANTAGE: Who was actually in charge of R&D? And other question...

admin — Wed, 20 Aug 2008 12:18:00 -0500

Roy Poses addresses many of the controversial issues raised by the Annals of Internal Medicine article "The ADVANTAGE seeding trial: a review of internal documents" in "Bad Seed: the ADVANTAGE Trial of Vioxx."

I wish to raise a few additional questions:

FDA Draft Report: No Risk From BPA In Food Containers

admin — Sat, 16 Aug 2008 00:00:00 -0500

A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday.

FDA Warns Consumers Not to Eat Certain Mussel Products from Bant...

admin — Fri, 15 Aug 2008 19:30:00 -0500

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.

FDA approves first drug for Huntington's disease

admin — Fri, 15 Aug 2008 00:00:00 -0500

(University of Rochester Medical Center) The US Food and Drug Administration today approved tetrabenazine, the first drug approved for use in the United States to treat Huntington's disease, a fatal, inherited neurodegenerative disorder for which there is no cure.

FDA Warns Consumers About Potential Problems at Two Baltimore Ph...

admin — Fri, 08 Aug 2008 19:00:00 -0500

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

Actavis Totowa Announces Voluntary Recall at the Retail Level of...

admin — Mon, 04 Aug 2008 10:00:03 -0500

Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.