The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH).

FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

The U.S. Food and Drug Administration (FDA) and its counterpart agencies in the Mexican government, the National Service for Agroalimentary Public Health, Safety and Quality (SENASICA) and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), are expanding their collaboration to reduce the risk of contamination of food that moves across the U.S.-Mexican border.

The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

At the request of the U.S. Food and Drug Administration, U.S. Marshals, yesterday, seized seafood products manufactured by the Meiko Food Co., South El Monte, Calif., because the products are adulterated.

The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after this week’s expected hurricane-related rain, possible flooding and power outages.

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.