Popcorn Palace Issues Allergy Alert on 1-Gallon Value Bag Products

Popcorn Palace of Schiller Park, IL, is issuing this statement to alert people with allergies to Peanuts, Tree Nuts, Milk, Soy, and Wheat that some of our 1-Gallon Value Bags contain the undeclared ingredients. Bags were shipped with the ingredient and allergen information not applied directly to the immediate container and important allergen information may not have reached the end consumer.

Consumer Alert: Undeclared Milk In Gollo Brand "Pan Dominicano (Dominican Bread)"

New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers to undeclared milk in “Pan Dominicano (Dominican Bread)”packaged and distributed by Gollo Desserts located at 349 Suydam St. in Brooklyn, NY. People who have severe sensitivity to milk may run the risk of serious or life-threatening reactions if they consume this product.
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FDA approves mechanical cardiac assist device for children with heart failure

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.

The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies

Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY)

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.

FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk Tobacco Products

Today, the Institute of Medicine released a report on the design and conduct of studies which the FDA will take into consideration in the assessment and ongoing review of modified risk tobacco products. A modified risk tobacco product is any tobacco product sold or distributed for use to lower the harm or risk of tobacco-related disease associated with other tobacco products.