FDA News Digest May 10, 2004 ________________________________________________
THIS WEEK'S NEWS -- FDA to Determine Health Significance of Low Furan Levels in Food -- FDA OKs Drug That Improves the Effects of Other Injected Therapies -- FDA Turns Down Request to Market 'Plan B' OTC; Outlines Path for Future Approval -- First Insulin Drug Treatment for Diabetic Dogs Receives FDA Approval -- Slaughtered Texas Cow With Nervous System Symptoms Investigated -- FDA to Modernize Good Manufacturing Practices for Food Products -- British Man Charged in Extortion Plot Involving Tainted Food Items -- FDA, Alliance to Boost Outreach Efforts for Hispanic American Consumers -- Proposal Would Streamline FDA Review Process for Combination Products -- Recalls/Market Withdrawals -- Public Meetings ________________________________________________ FDA to Determine Health Significance of Low Furan Levels in Food FDA will undertake a scientific assessment of the health significance of very low levels of furan -- a chemical produced by heating -- in certain foods. Some animal data suggest that high levels of furan might be cancer-causing, but the effect in humans, especially at very low levels, is unknown. http://www.fda.gov/bbs/topics/news/2004/NEW01065.html FDA OKs Drug That Improves the Effects of Other Injected Therapies FDA has approved Vitrase (hyaluronidase for injection) to be used in combination with other injected drugs to increase their absorption and dispersion. Vitrase has been shown to be valuable in combination with local anesthetics in eye surgery. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01287.html FDA Turns Down Request to Market 'Plan B' OTC; Outlines Path for Future Approval FDA has issued a "not approvable" letter to Barr Labs indicating that the company must provide more information to gain approval to sell its "Plan B" contraceptive over the counter. The agency based its action primarily on the lack of data regarding the product's use in adolescents under 16 years old. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01064.html Questions and answers: http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm First Insulin Drug Treatment for Diabetic Dogs Receives FDA Approval FDA has approved Vetsulin, a pig-derived product that is the first drug approved for treating diabetic dogs. Before this approval, veterinarians treated canine diabetes with human insulin, which is less compatible with a dog's metabolic system. Experts estimate that one in 200 dogs will develop diabetes. http://www.fda.gov/bbs/topics/news/2004/NEW01060.html Slaughtered Texas Cow With Nervous System Symptoms Investigated After learning April 30 that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal feed, FDA began an investigation that tracked down all the implicated material and now will allow it to be used for swine feed only. The agency took immediate action because cattle with bovine spongiform encephalopathy, or mad cow disease, can exhibit such symptoms. http://www.fda.gov/bbs/topics/news/2004/NEW01061.html FDA to Modernize Good Manufacturing Practices for Food Products Noting significant changes in food production technology, as well as a better understanding of foodborne illness, FDA plans to modernize the good manufacturing practices that are a crucial part of controlling food safety problems. The agency will hold three public meetings this summer to solicit input on the modernization effort. http://www.fda.gov/bbs/topics/news/2004/NEW01063.html British Man Charged in Extortion Plot Involving Tainted Food Items After sending several adulterated food items to a grocery chain and demanding money to prevent poisoned food from being placed on the shelves, British citizen David Ian Dickinson was charged with extortion and tampering. FDA's Office of Criminal Investigations assisted the Federal Bureau of Investigation in investigating the case. http://www.fda.gov/bbs/topics/news/2004/doj0507.html FDA, Alliance to Boost Outreach Efforts for Hispanic American Consumers FDA has signed an agreement with the National Alliance for Hispanic Health to help improve access to health information in Hispanic communities. Goals of the collaboration include expanding access to Spanish-language health information and enhancing dialogue between FDA and Hispanic leaders on health issues. Press release (English): http://www.fda.gov/bbs/topics/news/2004/NEW01062.html Press release (Spanish): http://www.fda.gov/bbs/topics/NEWS/spanish/NEW01062.html Proposal Would Streamline FDA Review Process for Combination Products An FDA proposed rule would establish a simplified process to determine the appropriate FDA component for reviewing applications for combination products. A growing product category, combination products contain some combination of a drug, medical device, or biological product. For example, a drug-eluting stent combines a drug with a medical device. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01288.html _______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Oh Yes Korean Cookies (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/kenneth05_04.html For a listing 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 ________________________________________________________________ PUBLIC MEETINGS May 13-14 -- FDA/NIH Joint Symposium on Diabetes will examine the current state of diabetes prevention and treatment (Bethesda, Md.) http://www.niddk.nih.gov/fund/other/FDA-NIH/index.htm May 18-19 -- FDA Science Forum will showcase FDA's scientific achievements, present topics of interest to FDA and its constituents, and promote internal and external scientific collaborations. (Washington, D.C.) http://www.cfsan.fda.gov/%7Efrf/sxsfin04.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. Our next posting will be May 17. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
