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.
Category Archives: Food Safety News
FDA approves Cialis to treat benign prostatic hyperplasia
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 Outlines Plans for an Outside Network of Scientific Experts
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 network through Dec. 30, 2011.
FDA approves gel to stop blood flow during blood vessel surgery
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 outlines steps to spur biomedical innovation, improve health of Americans
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.
Thumb Oilseed Recalls Soy Flour (Utilized To Manufacture Human and Animal Food) Due To Salmonella Contamination
Thumb Oilseed Producer’s Cooperative of Ubly, Michigan is recalling 2623, 40 lb. bags and 360, 1500 lb. totes of soybean flour; in addition to 924, .08 ton loads of bulk soy meal because they may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products.
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FDA: New transparency report outlines proposals for enforcement data, for public comment
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
FDA works to improve science used to approve medical devices
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.
FDA awards three grants to stimulate development of pediatric medical devices
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.
FDA seeks comment on streamlined review of lower risk, new technology, devices
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