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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Approves First Generic Risperidone to Treat Psychiatric Conditions: first
article | second
article
The U.S. Food and Drug Administration today approved the first generic
versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic
drug used for the treatment of schizophrenia, bipolar disorder, and other
psychiatric conditions. [ Read
more ]
FDA
Lifts Warning About Eating Certain Types of Tomatoes
After a lengthy investigation, the FDA has determined that fresh tomatoes
now available in the domestic market are not associated with the current
outbreak. As a result, the agency is removing its June 7 warning against
eating certain types of red raw tomatoes. [ Read
more ]
FDA
Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals
seized various animal food products stored under unsanitary conditions
at the PETCO Animal Supplies Distribution Center located in Joliet, Ill.,
pursuant to a warrant issued by the United States District Court in Chicago.
[ Read
more ]
United
States and China Outline Progress on Agreement on Food and Feed Safety
(HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed
a Joint Progress Statement today with the Honorable Li Changjiang, Minister
of the General Administration of Quality Supervision, Inspection, and
Quarantine (AQSIQ) of the People?s Republic of China. The document outlines
steps taken by both nations in implementing the 2007 Memorandum of Agreement
(MOA) on food and feed safety. [ Read
more ]
FDA
Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved
the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic
device that stimulates the diaphragm and allows certain spinal cord injury
patients to breathe for at least four hours a day without a mechanical
ventilator. [ Read
more ]
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 also 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 Internet. [ 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 make safety-related changes to prescribing information, 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 people with dementia.
[ Read
more ]
FDA,
European Medicines Agency to Consider Additional Test Results When Assessing
New Drug Safety
In the first use of a framework allowing submission of a single application
to the two agencies, the Food and Drug Administration (FDA) and the European
Medicines Association (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 provide additional
information about drug-induced damage to kidney cells, also 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 request 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 this budget amendment and pending Administration
legislative proposals to strengthen FDA. [ Read
more ]
FDA
Warns Consumers Nationwide Not to Eat Certain 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 certain 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, this week asked Science Board Chairwoman Barbara
J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical
School, to establish 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 Select 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 provide 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 Certain 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 certain types of raw red tomatoes and products containing raw red tomatoes.
The bacteria causing the illnesses are Salmonella serotype Saintpaul,
an uncommon type of Salmonella. [ Read
more ]
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