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 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: 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
Thorntons Recalls Garden Salad and Chef Salad Because of Possible Health Risk
Louisville, KY – Thorntons, Inc. is recalling its 6 oz Garden Salads and 5.6 oz Chef Salads because they have the potential to 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Kraft Foods Voluntarily Recalls Three Varieties of Velveeta Shells & Cheese Microwaveable Cups With Limited “Best When Used By� Dates
Kraft Foods Global, Inc. is voluntarily recalling three varieties of Velveeta Shells & Cheese Single Serve Microwaveable Cups with limited “best when used by� dates as a precaution due to the possible presence of small, thin wire bristle pieces.
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The U.S. Food and Drug Administration today issued draft guidance for manufacturers that updates and streamlines the de novo review process used for certain innovative, low to moderate-risk medical devices that do not meet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
Jensen Farms Includes IN, LA, and WI in Cantaloupe Recall Notification
Jensen Farms of Holly, CO is including whole cantaloupes shipped to the states of Indiana, Louisiana and Wisconsin in its September 14th recall notification. As part of its ongoing internal review of shipment records, Jensen Farms has identified shipments to these three states as part of the September 14 recall.
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True Leaf Farms Expands Voluntary Recall of Bagged, Chopped Romaine
True Leaf Farms is expanding its voluntary recall of romaine to include 2,498 cartons of chopped or shredded romaine because of the potential of contamination with Listeria
monocytogenes. The initial recalled product was shipped between September 12 and 13 to a retail food service distributor in Oregon who further distributed it to at least two additional states, Washington and Idaho
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FDA Drug Safety Podcast for Healthcare Professionals: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone
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.
True Leaf Farms Announces Voluntary Recall of Bagged, Chopped Romaine
True Leaf Farms is voluntarily recalling 90 cartons of chopped romaine because of the potential of contamination with Listeria monocytogenes. The recalled product was shipped between September 12 and 13 to an institutional food service distributor in Oregon who further distributed it to at least two additional states, Washington and Idaho.