Food and Drug Administration Press Releases - Thu, 17 Jun 2008 23:46:00 GMT Press releases from FDA http://www.fda.gov en-us Thu, 17 Jun 2008 23:46:00 GMT tina.gilliam@fda.hhs.gov 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.
FDA Reaches Settlement with California Hearing Device Maker - Thu, 17 Jul 2008 14:06:00 GMT The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law.
FDA Revises Process for Responding to Drug Applications - Wed, 09 Jul 2008 13:40:00 GMT The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs - Tue, 08 Jul 2008 17:51:00 GMT The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.
FDA Approves New Genetic Test for Patients with Breast Cancer - Tue, 08 Jul 2008 13:31:00 GMT The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).
FDA Food Protection Plan Shows Significant Progress - Wed, 02 Jul 2008 13:52:00 GMT 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 - Mon, 30 Jun 2008 20:13:00 GMT 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 - Thu, 19 Jun 2008 20:23:00 GMT 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.
United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) - Wed, 18 Jun 2008 16:28:00 GMT 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 Approves Diaphragm-Pacing Device - Wed, 18 Jun 2008 14:17:00 GMT 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.
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' - Tue, 17 Jun 2008 14:30:00 GMT 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 - Mon, 16 Jun 2008 19:38:00 GMT 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.
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety - Thu, 12 Jun 2008 17:14:00 GMT 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.
Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) - Mon, 09 Jun 2008 23:57:00 GMT 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.
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