The U.S. Food and Drug Administration has approved a stent graft system that provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening abdominal aortic aneurysm.
Category Archives: Drug Safety Information Podcasts
The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery
The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery.
FDA Enters Consent Decree of Permanent Injunction in NY Tissue Residue Case
The U.S. Food and Drug Administration (FDA) today announced that Raymond L. Martin, a sole proprietor operating Corner View Dairies, located in Lyons, NY, has signed a consent decree of permanent injunction. The decree prohibits Mr. Martin from selling animals with illegal levels of animal drugs and from administering drugs to animals without proper record-keeping and veterinary oversight/supervision.
FDA warns consumers not to eat Wegmans’ bulk Turkish pine nuts
The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts purchased from unlabeled plastic bulk containers at Wegmans Food Markets, Inc. or any food items they may have prepared using the bulk Turkish pine nuts, such as pesto, salads, or baked goods.
FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).
The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA.
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
FDA approves Onfi to treat severe type of seizures
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.
FDA: U.S. Marshals seize food products at Illinois warehouse
U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warrant issued by the U.S. District Court for the Northern District of Illinois.
FDA proposes lower risk classification, special controls for external pacemakers
Today the U.S. Food and Drug Administration issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk).
FDA approves Ferriprox to treat patients with excess iron in the body
The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.