The U.S. Food and Drug Administration and federal partners today released the Food Related Emergency Exercise Boxed (FREE-B) set, a Web-based collection of scenarios that will help government regulators, public health organizations and the food industry test their readiness for food-related emergencies, such as a human health emergency caused by an unintentional contamination of produce with E. coli O157:H7.

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

The FDA is warning consumers not to drink raw milk from Tucker Adkins Dairy of York, S.C. Three confirmed cases and five probable cases of campylobacteriosis in North Carolina are associated with raw milk from Tucker Adkins Dairy.

The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.

The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.

The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.

On July 1, the U.S. Food and Drug Administration approved Xarelto (rivaroxaban) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.

The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA) and that new authorities to suspend the registration of food facilities and to administratively detain food that it has reason to believe are adulterated or misbranded have gone into effect.