Life Sciences Regulation News

FDA Latest News
	What's New in Food
	Food safety and nutrition announcements, and newly posted documents on the FDA/Foods website.
	Egg Safety Final Rule
	Egg Safety Final Rule - The regulation requires preventive measures during the production of eggs in poultry houses and requires subsequent refrigeration during storage and transportation.
FDA CDRH Latest News
	Summary Information for: OraQuick HCV Rapid Antibody Test
	Labeling, Approval Order, and Summary of Safety and Effectiveness for OraQuick HCV Rapid Antibody Test (P080027).
	Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027
	The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...
	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period
	The FDA is reopening until 9/7/2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...
FDA News
	FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist
	The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.
	FDA Approves Drug for Chronic Drooling in Children
	The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.
	New Early Detection System Helps FDA Identify More than 100 Food Safety Problems in First 7 Months
	More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration?s new electronic portal in its first months of operation, the agency said today.
FDA Recalls
	Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient
	Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II. Nutraloid Labs Inc. has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of ejaculoid XXTREME, Lot 79935, and stimuloid II, Lot 79936, by the FDA found that the products contain sulfoaildenafil, similar in structure to Sildenafil.
	Specialty Farms, LLC Expands Recall of Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk
	Specialty Farms is voluntarily recalling certain Alfalfa sprout products with a best if sold by date of ?8/3/2010? and ?8/1/2010? that has the potential to be contaminated with Listeria Monocytogenes (LM). Listeria Monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
	Dulcería Chepito Emite una Alerta por Alergenos en Sus Productos "Almejas"
	Dulcería Chepito localizada en Cabo Rojo, PR está llevando a cabo un recogido voluntario del producto "Chepito Dulces Tropicales - Almejas" empacados en unidades de 6 oz. Este producto contiene huevos y no está declarado en la etiqueta. Personas que son alérgicas al huevo están en riesgo de serias reacciones alérgicas si consumen estos productos.