FDA News Digest January 27, 2003 __________________________________________________________________ FDA Issues Guidance for Collecting Race, Ethnicity Data in Clinical Trials FDA has published a draft guidance for industry that recommends categories for collecting safety and effectiveness data during clinical trials for ethnic and racial demographic groups. By standardizing these categories, FDA hopes to enhance early identification of differences in response to medical products among racial and ethnic groups during the evaluation of these products. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01193.html __________________________________________________________________ Asthma Drug Study Halted; Data Show Potential Increased Hazards for Some GlaxoSmithKline, maker of the asthma treatment Serevent Inhalation Aerosol, has discontinued a post-marketing study of the drug after experiencing a shortfall in intended enrollment. The study, begun in 1996, did yield interim data suggesting that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths in certain patients. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01192.html __________________________________________________________________ RECALLS The following products, or certain lots of them, have recently been recalled for the reasons shown. Go to the linked page for more information: Elan Nutrition Ultimate Lo Carb Bar, Chocolate Brownie Nut Flavor (undeclared peanuts): http://www.fda.gov/oc/po/firmrecalls/elan1_03.html Ful-Flav-R Diced Red Bell Peppers (botulism risk): http://www.fda.gov/oc/po/firmrecalls/fulflavr01_03.html __________________________________________________________________ PUBLIC MEETINGS Jan. 29 Meeting, Satellite Broadcast to Discuss Bioterrorism Act FDA will sponsor a public meeting Jan. 29 to discuss two sections of the Bioterrorism Act of 2002 regarding registration of food facilities and prior notice of imported food shipments. The meeting will be broadcast by satellite to locations across the country, including sites in California, Colorado, Illinois, Maryland, New York, Texas, and Washington state. Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-660.htm Meeting registration: http://www.fda.gov/oc/bioterrorism/meeting01_29.html FDA's 2003 Science Forum Now Open for Registration Interested persons can register now for the 9th Annual FDA Science Forum, to be held in Washington, D.C., April 24-25. Open to the public, the forum brings FDA scientists together with industry, academia, consumers, and others to share information about the science-based mission of the agency. Discussion topics for this year's forum include risk assessment and public health initiatives in the wake of 9/11/01. http://www.dcscienceforum.org For a list of more upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. __________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be February 3. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
