FDA News Digest January 20, 2004 ______________________________________________________________ FDA Sees Improvements in Approval of Innovative Drugs in 2003 FDA reports that in 2003 the agency made improvements over the previous year in approvals of drugs and biologics. This included decreases in the time taken to review and approve most applications. As part of this performance, FDA approved 21 products with active ingredients never before marketed in the United States. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html ______________________________________________________________ FDA Advances Consumer Health and Safety in 2003 FDA has released a report highlighting some of the agency's priorities and initiatives to protect consumer health and safety in 2003. The report describes how FDA plans to build on these initiatives in 2004. Highlighted agency programs include those that combat new forms of terrorism and emerging diseases, crack down on false products and claims, and reduce preventable medical errors. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01004.html ______________________________________________________________ FDA Deputy Commissioner Joins BSE Delegation to Japan and Korea FDA Deputy Commissioner Lester M. Crawford, D.V.M., is a member of a U.S. government delegation to Japan and Korea to discuss bovine spongiform encephalopathy (BSE or mad cow disease) with officials from the two Asian countries. The group, which departed Jan. 20, will discuss all aspects of the first confirmed case of BSE in the United States, reported on Dec. 23. Crawford is the delegation's expert on FDA-related aspects of BSE, especially the "animal feed" rule, designed to help prevent the spread of BSE in the United States. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01006.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Lactalis USA President Brie Soft-ripened Cheese Double Cream in Green Foil (herb) and Gold Foil (plain); expanded recall (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/lactalis01_04.html 7-Eleven "Big Eats" Stacked Ham/Turkey Club on Buttermilk Bread (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/7Eleven01_04.html ______________________________________________________________ Latest FDA Consumer Magazine Available Online The January-February 2004 issue of FDA Consumer has articles on the following topics: * Fighting terrorism -- FDA's commissioner has made counterterrorism a top priority. * Preventing Listeria contamination -- Follow these tips when handling or preparing food. * Obesity -- The food industry, consumer groups and others are helping FDA tackle this public health problem. * Keeping pets (and people) healthy -- Some easy-to-follow steps. * Cervical cancer -- Regular screening tests can help women prevent this disease. * Ultrasound "keepsakes" -- FDA discourages expectant mothers from receiving casual images from this technology. * Advisory committees -- These forums help FDA make regulatory decisions. * Older Hispanic Americans -- FDA has teamed up with the Administration on Aging to help prevent diseases in Hispanic American seniors. Also included is an editorial on the importance of animals and animal health. The issue is online at http://www.fda.gov/fdac/104_toc.html. _______________________________________________________________ PUBLIC MEETINGS 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 January 26. 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