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| FDA Food Protection Plan Shows Significant Progress 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 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... FDA, European Medicines Agency to Consider Additional Test Results When Assessing... 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 th... 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. 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. 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. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisph... 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. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions 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. Sucampo Pharmaceuticals Obtains FDA Approval For AMITIZA(R) For The Treatment Of ... Sucampo Pharmaceuticals, Inc., (NASDAQ: SCMP, Sucampo Pharmaceuticals) and Takeda Pharmaceutical Company Limited (TSE: 4502, Takeda) and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results In A Phase 2b Cl... Tioga Pharmaceuticals, Inc. announced the results of a recent Phase 2b study of its oral kappa opioid receptor agonist, asimadoline, which demonstrated statistically significant results in the treatment of Irritable Bowel Syndrome (IBS). Invivodata's EPRO Solution Captures Primary Efficacy Data Supporting Supplemental... invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, announced that its ePRO solutions - DiaryPRO® and SitePRO® - captured primary efficacy data that supported the recent U.S. Food and Drug Administration's (FDA) supplemental approval of Sucampo Pharmaceutical Inc. Callisto Pharmaceuticals Files IND For SP-304 (Guanilib) In Chronic Constipation ... Callisto Pharmaceuticals, Inc. (AMEX: KAL; FWB: CA4) announced that through its wholly-owned subsidiary, Synergy Pharmaceuticals, Inc. it filed an IND on April 2, 2008 with the FDA for SP-304 (also called Guanilib) for the treatment of chronic constipation and constipation-predominant irritable bowel syndrome. SP-304 is an analog of uroguanyli... IBS Symptoms Relieved By Home-Based Cognitive Behavioral Therapy Persons with irritable bowel syndrome (IBS) can relieve their symptoms as effectively by following a self-administered, at-home cognitive behavioral program as they can by undergoing a 10-week in-office program administered by a trained therapist, a new pilot study has shown. Anti-depressants May Benefit Some Patients With Irritable Bowel Disease Theories abound about the cause of Irritable Bowel Disease (IBD): Diet? Stress? Perhaps an infection? On the other hand, is it possible depression could be triggering the disease in some of the 20 per cent of Canadians suffering from this digestive system disorder? New research conducted by scientists in McMaster University's Intestinal Di... Impact On Productivity From Functional Gastrointestinal Disorders Measured By Study Those who suffer from common functional gastrointestinal disorders face work productivity losses and impairments in daily activity that amount to the loss of at least one day of work in a 40-hour workweek, according to a new study presented at the Annual Scientific Meeting of the American College of Gastroenterology. Functional gastrointestin... Dynogen Presents Results Of Its Positive Phase 2a IBS-c Study With DDP733 Dynogen Pharmaceuticals, Inc. announced the presentation of positive results from its Phase 2a clinical trial for DDP733 (pumosetrag) as a treatment for irritable bowel syndrome with constipation (IBS-c) at the Digestive Disease Week 2008 (DDW) scientific meeting. |
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