La compañía TWI Foods Inc. está retirando voluntariamente del mercado varias variedades de galletas y pan tostado (rusk) de marca Crispy. La Administración de Alimentos y Medicamentos (FDA), junto con la Agencia Canadiense de Inspección Alimentaria (CFIA) y TWI Foods Inc., están advirtiendo a la gente con alergias a la leche o almendras de no consumir galletas y pan tostado de marca Crispy. Los productos afectados contienen almendras y/o leche y no están claramente declarados en la etiqueta.

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

TWI Foods Inc. is voluntarily recalling several varieties of Crispy brand cookies and rusk. The Food and Drug Administration (FDA) along with the Canadian Food Inspection Agency (CFIA) and TWI Foods Inc., are warning people with allergies to milk or almonds not to consume Crispy brand cookie and rusk products. The affected products contain almonds and/or milk which are not clearly declared on the label.

The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents: the first provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products, and the second provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.

The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012.

The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards. If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products.

Dara Corrigan, associate commissioner for regulatory affairs for the U.S. Food and Drug Administration, and David M. Ketchmark, Acting U.S. Attorney for the Western District of Missouri, announced today that U.S. Marshals have seized drugs being held by Notions-n-Things Distribution of Bogard, Mo.

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).

Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.