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| Site Title: | Food and Drug Administration Home Page | ||
| Site Description: | "Home Page for the Food and Drug Administration (FDA)"> | Language: | en-us |
Fda RSS Details |
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FDA Acts To Avoid Shortage And Strengthen The Safety Of Sucraid The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.... |
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FDA Approves New Drug To Treat Severe Form Of Epilepsy The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.... |
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FDA Warns Public Of Extortion Scam By FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.... |
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FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.... |
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FDA Reports Nationwide Recall Of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, ... |
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FDA Approves Toviaz, A New Drug To Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.... |
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HHS/FDA Grants Tentative Approval For 75th Generic Anti-Retroviral Drug As Part Of President's Emergency Plan For AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opp... |
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FDA Statement On Release Of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.... |
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FDA Issues Warning Letters To Bayer HealthCare For Illegally Marketing Two Unapproved Drugs The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).... |
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FDA Approves Lung Valve To Control Some Air Leaks After Surgery The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.... |
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FDA Approves Updated Labeling For Psoriasis Drug Raptiva The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strateg... |
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FDA Creates Web Page With Drug Safety Information For Patients, Health Care Professionals Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs... |
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FDA Licenses For Marketing New Therapy For Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.... |
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FDA Approves Rapaflo For The Treatment Of Symptoms Due To An Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.... |
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FDA Launches Food Defense Awareness Training Kit For Employees In The Food Industry Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.... |
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FDA Licenses Drug To Prevent Joint Damage In Children With Hemophilia A The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.... |
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FDA Statement Following CHPA's Announcement On Nonprescription Over-the-Counter Cough And Cold Medicines In Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as th... |
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FDA Approves Use Of Temporary Pump To Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood ... |
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FDA And PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.... |
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FDA Detects Melamine Contamination In Flavored Drink The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a reca... |
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FDA Issues Interim Safety And Risk Assessment Of Melamine And Melamine-related Compounds In Food The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.... |
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FDA Awards $5.2 Million In Grants To Further Food And Feed Safety The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.... |
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FDA Awards Up To $2.5 Billion To Modernize Information Technology Over Ten Years The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.... |
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FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase The Risk Of Lou Gehrig's Disease A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease.... |
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FDA Updates Health Information Advisory On Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.... |
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FDA Warns Companies To Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products And Topical Drug Products Containing Papain The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.... |
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FDA Proposes Label Requirements For Refused Imported Foods The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.... |
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FDA Issues Draft Guidance On Regulating Genetically Engineered Animals The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE anima... |
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FDA Issues Warning Letters To Ranbaxy Laboratories Ltd., And An Import Alert For Drugs From Two Ranbaxy Plants In India The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical in... |
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FDA Approves Expanded Uses For Gardasil To Include Preventing Certain Vulvar And Vaginal Cancers The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.... |
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