FDA News Digest July 26, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Standard Format Established for Human Drug Clinical Trial Data -- Botox OK'd to Treat Severe Underarm Sweating -- Investigation Focuses on Tomatoes as Source of Illness in 5 States -- FDA Lauds House Passage of Food Allergen Labeling, Animal Drug Bill -- Schultz Named to Head FDA Devices and Radiological Health Center -- Metabolife, Founder Indicted for Lying to FDA about Ephedra Risks -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ Standard Format Established for Human Drug Clinical Trial Data FDA is establishing a standard format that sponsors of human drug clinical trials can use to submit data to the agency. Called the Study Data Tabulation Model (SDTM), the new format will automate the largely paper-based clinical trials research process and will foster easier communication and collaboration among clinical researchers. http://www.fda.gov/bbs/topics/news/2004/NEW01095.html Botox OK'd to Treat Severe Underarm Sweating FDA has approved Botox (Botulinum Toxin Type A) for the new purpose of treating a severe type of underarm sweating that cannot be managed by other treatments, such as prescription antiperspirants. Botox was first approved in 1989 for treating two rare eye disorders and since has been approved for other uses. http://www.fda.gov/bbs/topics/answers/2004/ANS01301.html Investigation Focuses on Tomatoes as Source of Illness in 5 States FDA and other state and federal officials are focusing on pre-sliced Roma tomatoes as a likely source of Salmonella contamination in food bought from deli counters at Sheetz gas stations. Since July 2, 289 Salmonella cases have been reported in Pennsylvania, Ohio, Maryland, Virginia, and West Virginia, and many appear to be related to the tomatoes. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01096.html Original announcement: http://www.fda.gov/bbs/topics/news/2004/NEW01090.html FDA Lauds House Passage of Food Allergen Labeling, Animal Drug Bill FDA is commending passage by the House of Representatives of a bill that will help consumers identify foods that can cause severe allergic reactions and separately will provide incentives for developing disease treatments for zoo animals, exotic species, and pets. The bill, passed already by the Senate, includes the Food Allergen Labeling and Consumer Protection Act and the Minor Use and Minor Species Animal Health Act. http://www.fda.gov/bbs/topics/news/2004/NEW01094.html Schultz Named to Head FDA Devices and Radiological Health Center FDA has named Daniel G. Schultz, M.D., as director of the agency's Center for Devices and Radiological Health. He will be responsible for FDA's review of all medical devices, as well as oversight of radiation-emitting products such as lasers and x-ray machines. Schultz brings to the job experience in various managerial positions at FDA and a strong background in general surgery, pediatric surgery, and family practice. http://www.fda.gov/bbs/topics/news/2004/NEW01093.html Metabolife, Founder Indicted for Lying to FDA about Ephedra Risks A California grand jury has indicted San Diego-based Metabolife International, Inc., and its founder, Michael J. Ellis, on charges of fraud and corruption concerning the health risks of the company's ephedra dietary supplements. The indictment charges that the firm lied to FDA when it said it had not received any reports of adverse effects from its ephedra product Metabolife 356. http://www.fda.gov/bbs/topics/news/2004/doj72204.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. Vitros Immunodiagnostic Products Troponin I Reagent Pack (lots 1110, 1130, 2510, 2530); used to aid in diagnosis of heart attack (produces random false positive results) http://www.fda.gov/cdrh/recalls/recall-060704.html Jane Jane and Wei Chuan brand Frozen Cuttle Fish Ball, Frozen Pollock Fish Ball, Shrimp Ball, Squid Nugget, Milkfish Ball, and Frozen Fish Ball (undeclared egg) http://www.fda.gov/oc/po/firmrecalls/weichuan07_04.html Haitai Mini Wafers; Cream and Strawberry flavors (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/kenneth07_04.html El Dorado Bakery brand Pan Tostado and Salpora De Arroz (undeclared milk protein) http://www.fda.gov/oc/po/firmrecalls/dorato07_04.html King Chief Dried Dehydrated Cole (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/kingchief07_04.html Elmas Apricots (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/sunrise07_04.html Fortuner's Dried Vegetable (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/starmark07_04.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ PUBLIC MEETINGS July 28-29 -- Research Strategies, Study Designs and Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection; Gaithersburg,Md. http://www3.cancer.gov/prevention/biomarkers2004/index.html Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. 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