The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and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.

The U.S. Food and Drug Administration has announced that the United States District Court for the Eastern District of California, Sacramento Division, entered a consent decree of permanent injunction against John C. Virtue, doing business as Virtue Calves, and Shannon L. Virtue for selling veal calves for use as food that contain illegal drug residues in violation of federal law.

The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.

The FDA is advising consumers not to eat Evergreen Produce brand alfalfa sprouts and spicy sprouts. The sprouts are possibly linked to 20 reported cases, including one hospitalization, of Salmonella Enteritidis in Idaho, Montana, New Jersey, North Dakota and Washington State. The strain of S. Enteritidis is rarely seen at this frequency.

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.