December 30, 2009FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010 FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Source: www.fda.gov FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE). Source: www.fda.gov FDA Launches New Pet Health and Safety Widget The U.S. Food and Drug Administration today launched its pet health and safety widget for consumers as part of an ongoing effort to provide timely, user-friendly, public health information. Source: www.fda.gov U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment. Source: www.fda.gov FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University. Source: www.fda.gov FDA Expands Presence Outside U.S. with Opening of Mexico City Post As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration today announced the opening of its Mexico City post. This is the Agency’s third post in Latin America and its tenth international post in the past 13 months Source: www.fda.gov FDA Debars Convicted Virginia Seafood Dealer from Importing Food for 20 Years A Virginia man sentenced to five years in prison for his role in a conspiracy to import catfish from Vietnam for fraudulent sale to avoid paying federal import tariffs has been barred from importing articles of food or offering such articles for import into the United States for the next 20 years, the U.S. Food and Drug Administration said today. Source: www.fda.gov # posted by Network @ 3:23 PM
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