food and drug administration fda

(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.

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.

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.

The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts distributed by Sunrise Commodities, based in Englewood Cliffs, New Jersey, after FDA tests confirmed the presence of Salmonella on the product.

FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and State public health and agriculture officials to investigate a multistate outbreak of Salmonella Enteritidis infections.

Wells Enterprises, Inc., in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Blue Bunny Personals ice cream 5.5 fl oz. because it was mispackaged and contains undeclared wheat.

In cooperation with the Food and Drug Administration (FDA), King International LLC Is initiating a recall of the Shoulderflex massager due to a report of a strangulation and death.

Consumers, retailers and catalog sellers are being advised to immediately stop using Shoulderflex massagers, and to safely dispose of them in the trash.

The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

This bold measure will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking.

Background

Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient.

FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.

(Cooney Waters Group, Inc.) Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the US Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age.

This is the first US approval of a meningococcal vaccine for this age group.