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 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 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.