Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).
Chocolate Decadence Issues Allergy Alert on Undeclared Milk in Multiple Lines of Chocolate Products
Chocolate Decadence, Eugene, Oregon, is recalling multiple lines of chocolate products because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Watkins Incorporated Issues Allergy Alert On Undeclared Milk In Soynilla
Watkins Inc. of Winona, MN, is recalling 1,535 units of its individual 7.7 ounce containers of SoyNilla, because it contains an undeclared milk ingredient. SoyNilla was distributed nationwide through the Watkins network of independent contractors, associates and mail orders.
FDA warns consumers of botulism risk in La Ruche tapenade, spreadable tomato paste
The FDA is warning consumers not to eat tapenade or spreadable dried tomato paste manufactured by the French food company La Ruche. French health authorities have reported an outbreak of botulism in France linked to the company’s products sold under the brand names “Les délices de Marie-Claire,” “Terre de Mistral” and Les Secrets d’Anaïs.” Eight adults are currently suffering from respiratory failure as a result of eating foods containing the neurotoxin produced by Clostridium botulinum.
BUI Natural Tofu Issues Allergy Alert on Undeclared Soy and Wheat in Their Shrimp Salad Roll and Vegetarian Salad Roll
BUI Natural Tofu, Portland, Oregon is voluntarily recalling their Shrimp Salad Roll and Vegetarian Salad Roll because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and wheat run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA: Pilot projects to explore ways to trace sources of foodborne illness
The U.S. Food and Drug Administration today said that two new pilot projects will enhance the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
FDA Drug Safety Podcast for Healthcare Professionals: Drug labels for the Tumor Necrosis Factor-alpha (TNFa) blockers now include warnings about infection with Legionella and Listeria bacteria
On September 7, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha, or TNFa, blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria.
FDA Drug Safety Podcast for Healthcare Professionals: Serious allergic reactions reported with the use of Saphris (asenapine maleate)
On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris, active ingredient asenapine maleate.
FDA Drug Safety Podcast for Healthcare Professionals: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)
On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved an update to the drug label for Reclast, active ingredient zoledronic acid, to better inform healthcare professionals and patients of the risk of renal failure.
FDA Drug Safety Podcast for Healthcare Professionals: Updated drug labels for pioglitazone-containing medicines
On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.