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).
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.
On October 11, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that the leukemia drug Sprycel, active ingredient dasatinib, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, known as pulmonary arterial hypertension, or […]
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011.
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.
The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
The U.S. Food and Drug Administration and the National Institutes of Health today announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations.
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.
FDA’s Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also conduct a 12-week pilot of […]
The U.S. Food and Drug Administration has approved LeGoo, a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops.
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.
The U.S Food and Drug Administration today released 8 new draft proposals in a report titled “Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products.
The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.
The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet the requirements for clearance under the better-known 510(k) review process
On September 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.
The U.S. Food and Drug Administration announced today that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc., and Hill Labs, Inc. (collectively referred to as “Hill”), and individuals Jerry S. Roth and Rosario G. Ramirez, from introducing adulterated drugs into interstate commerce.
The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.
The U.S. Food and Drug Administration has cleared the Kimberly-Clark Pediatric/Child Face Mask, designed to be worn in hospitals and health care facilities to help reduce the spread of airborne respiratory tract bacteria, viruses, and other pathogens.