FDA News Digest September 13, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- FDA Will Allow 'Qualified' Health Claim for Omega-3 Fatty Acids in Foods -- Drug Approved to Help Patients Manage Diabetes-Related Pain -- Walcoff Appointed to Direct FDA External Relations Programs -- Recalls/Market Withdrawals -- Public Meetings _____________________________________________________________ FDA Will Allow 'Qualified' Health Claim for Omega-3 Fatty Acids in Foods Foods that contain two specific omega-3 fatty acids can now carry a "qualified" health claim for reduced risk of coronary heart disease. These fatty acids are typically found in oily fish such as salmon, tuna, lake trout, and herring. Qualified health claims are not conclusive but are supported by credible scientific evidence. http://www.fda.gov/bbs/topics/news/2004/NEW01115.html Drug Approved to Help Patients Manage Diabetes-Related Pain FDA has approved Cymbalta, an oral drug for managing pain related to diabetic peripheral neuropathy, a disorder characterized by burning, tingling or numbing sensations in the feet, legs or hands. Peripheral neuropathy affects about 62 percent of diabetic Americans. http://www.fda.gov/bbs/topics/news/2004/NEW01113.html Walcoff Appointed to Direct FDA External Relations Programs FDA has named Sheila Dearybury Walcoff to be the agency's associate commissioner for external relations. She will oversee FDA's programs for external audiences, which include patient groups, the news media, professional organizations, and regulated industry. She also will act as a senior adviser to Lester M. Crawford, D.V.M., FDA acting commissioner. http://www.fda.gov/bbs/topics/news/2004/NEW01114.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS No recalls were reported in the past week. 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 Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html Oct. 13-14 -- Animal Models and Correlates of Protection for Plague Vaccines; Gaithersburg, Md. http://www.fda.gov/cber/meetings/plague101304.htm 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 September 20. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
