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Recent FDA News
FDA RECENT
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FDA Food Protection Plan Shows Significant Progress
04 Jul 2008
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America?s food supply since unveiling its Food Protection Plan in November 2007.
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
01 Jul 2008
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.
FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
20 Jun 2008
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.
FDA Approves Diaphragm-Pacing Device
19 Jun 2008
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.
United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
19 Jun 2008
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.
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
18 Jun 2008
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.
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
17 Jun 2008
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.
Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
13 Jun 2008
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.
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
13 Jun 2008
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.
FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
08 Jun 2008
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.
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