Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today.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.
Category Archives: Food & Drug Recalls
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 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.
Velvet Creme Popcorn Co. Issues Allergy Alert On Undeclared Milk, Soy, And Wheat In Products
Velvet Creme Popcorn Co. of Westwood, Kansas, is issuing this statement to alert people with allergies to Milk, Soy and Wheat that several of our products contain the undeclared ingredients. These people run a risk of serious or potential life threatening allergic reaction if they consume the following products
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.
Rising Moon Organics Announces a Voluntary Recall of One Code Date of Mislabeled Mediterranean Garlic & Herb Ravioli Due to Undeclared Soy Allergen
Rising Moon Organics® today issued a voluntary recall of Rising Moon Organics Mediterranean Garlic & Herb Ravioli, a frozen product, because of an incorrect back label on some packages. This mislabeling incident resulted in an undeclared allergen (Soy).
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Winn-Dixie Issues Voluntary Recall on Bulk Gummy Bears
Winn-Dixie Stores, Inc. (NASDAQ: WINN), is voluntarily recalling Sunrise Assorted Flavor Gummy Bears sold in the self-serve bulk area of select store produce departments between November 14 and December 13 due to a remote possibility of metal contamination. The gummy bears included in this recall have been sold in five Winn-Dixie stores in Florida and Louisiana:
Rhee Bros., Inc. Issues Allergy Alert on Undeclared Egg in "Assi" Brand Korean Cake (Gyeong Dan)
Rhee Bros.,Inc. of Hanover, MD, is recalling its 8 ounce packages of “ASSI” brand Korean Cake (Gyeong Dan) because they contain undeclared egg. People who have allergies to eggs, run the risk of serious life-threatening allergic reaction if they consume these products.
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FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.
FDA issues Warning Letters for misleading advertising of Lap-Band
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.