FDA Warns Individuals and Firms to Stop Selling Fake Cancer ‘Cures’

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA plus warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the World Wide Web. Read more

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of “conventional” antipsychotic drugs to manufacture safety-related changes to prescribing info, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older citizens with dementia. Read more

FDA, European Medicines Agency to Consider Additional tryout Results When Assessing New Drug Safety

In the first use of a framework allowing submission of a individual application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines organization (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or “biomarkers” found in urine that can supply additional info about drug-induced damage to kidney cells, plus known as renal toxicity. Read more

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)

HHS Secretary Leavitt today announced that the Administration is amending its budget desire for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on that budget amendment and pending Administration legislative proposals to strengthen FDA. Read more

FDA Warns Consumers Nationwide Not to Eat positive Types of Raw Red Tomatoes

The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of convinced raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Read more

FDA’s Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A

Frank M. Torti, M.D., M.P.H., the FDA’s principal deputy commissioner and chief scientist, that week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to set up a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Read more

FDA Announces New Labeling Changes for Regranex

The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Read more

FDA Takes Action against Seafood Processing Company, Executives

The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain’s choose Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. Read more

FDA Announces Limited Return of Heartworm Drug to U.S. Market

ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to supply for safe, appropriate use of the product while minimizing risk to dogs. Read more

FDA Warns Consumers in New Mexico and Texas Not to Eat assured Types of Raw Red Tomatoes

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of undoubtful types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an strange type of Salmonella. Read more

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