food and drug administration

American Society of Hematology statement on critical methotrexat...

EurekAlert! - Cancer  Tue, 02/14/2012 - 23:00

(American Society of Hematology) Members of the American Society of Hematology are on the front lines of dealing with the country's severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia.

This morning the Food and Drug Administration reported that two manufacturers plan additional releases at the end of this week, at the end of February, and continuing into March, which it anticipates will meet all patient needs.


 

FDA approves new skin cancer drug first tested in Arizona by Sco...

EurekAlert! - Cancer  Tue, 01/31/2012 - 23:00

(The Translational Genomics Research Institute) A new skin cancer drug tested for the first time in the world five years ago at the Virginia G.

Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the US Food and Drug Administration, a remarkable accomplishment in new drug development.


 

Perfect Image Solutions, LLC Issues Voluntary Recall of Unapprov...

Food and Drug Administration--Recalls  Fri, 01/20/2012 - 11:48

Perfect Image Solutions, LLC is voluntarily recalling all lots of Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level.

The products are deemed “unapproved new drugs� under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.


 

Avastin disappoints against ovarian cancer

Seattle Post-Intelligencer: Health and Fitness  Wed, 12/28/2011 - 16:00

Avastin disappoints against ovarian cancer Associated Press


 

HIV/AIDS vaccine developed at Western proceeding to human clinic...

EurekAlert! - Medicine and Health  Mon, 12/19/2011 - 23:00

(University of Western Ontario) The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.Developed by Dr.

Chil-Yong Kang and his team at the University of Western Ontario, with the support of Sumagen Canada, the vaccine (SAV001) has already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks.


 

FDA Classifies Voluntary Physician Advisory Letter on Riata and ...

Food and Drug Administration--Recalls  Thu, 12/15/2011 - 18:36

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.

The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians.


 

We Can’t Wait: Obama Administration makes more progress to red...

HHS News and Events  Wed, 12/14/2011 - 23:01

Washington, DC - Today, in response to President Obama’s Executive Order of Oct. 31, 2011, the Obama Administration is issuing an interim final rule that will help prevent prescription drug shortages.

The rule will require manufacturers that are the only producer of certain critical drugs to report to the Food and Drug Administration all interruptions in manufacturing of products.

The rule builds on FDA’s current work to ensure Americans have access to the medicine they need.


 

Pacific International Marketing Voluntary Recalls Product Becaus...

Food and Drug Administration--Recalls  Sat, 12/10/2011 - 09:36

Pacific International Marketing (“Pacific”) is working with the Food and Drug Administration (“FDA”) and California Department of Public Health to coordinate a recall of Cilantro for potential contamination with Salmonella.

FDA has advised that a sample of Pacific Cilantro has tested positive for Salmonella.


 

FDA to yank homeopathic ‘weight loss’ products

NYDailyNews.com - Health - NY Daily News  Tue, 12/06/2011 - 16:18

The Food and Drug Administration is cracking down on certain weight-loss products labeled as 'homeopathic.' The FDA and the Federal Trade Commission are working to yank products that contain human chorionic gonadotropin.