FDA News Digest January 13, 2003 __________________________________________________________________
FDA Approves New Labels for Postmenopausal Hormone Therapy Based on data from the landmark Women's Health Initiative study, FDA has approved changes to labeling of all estrogen and estrogen with progestin products for use by postmenopausal women. The changes include a boxed warning that reflects new risk information and emphasizes individual decisions that balance the benefits and potential risks of these products. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00863.html Fact sheet: http://www.fda.gov/bbs/topics/factsheets/2003/fs1.html More information: http://www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm __________________________________________________________________ Phase Two of Consolidating Certain Biologic and Drug Reviews Concluded FDA has completed the second phase of its consolidation of certain biological product reviews into the agency's Center for Drug Evaluation and Research, a move begun last year to produce a more efficient, effective and consistent review system for human drugs and biologics. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01188.html __________________________________________________________________ Latest FDA Consumer Magazine Available Online The January-February 2003 issue of FDA Consumer, available online at http://www.fda.gov/fdac/103_toc.html has articles on the following topics: * West Nile virus -- FDA is taking action to protect the nation's blood supply from this mosquito-borne virus. * Acrylamide -- FDA scientists are working to determine if the low levels of acrylamide found in certain cooked foods pose a risk. * Drug research and children -- FDA is taking steps to ensure that drugs are safe and effective for children. * Pain relievers -- Experts urge care to avoid accidental overdosing and the risks for liver damage and other serious health problems. * Depression -- This disorder affects millions of Americans. FDA has taken steps that may pave the way for more effective treatments. * Decorative contact lenses -- Misusing these lenses can cause serious eye damage. * Monosodium glutamate -- The flavor enhancer MSG has been shown to be safe when consumed at typical levels. * FDA's new commissioner -- Mark B. McClellan, M.D., says recent congressional action sets the stage for "substantial expansion" of the agency's mission. The issue also has: * a commentary on pediatric drug research and mental illness * a report on a pair of Wisconsin companies that received stiff fines for selling a yeast product intended for animals as a human food component * the "fda.gov" column, which reviews and previews health-related websites. ____________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be January 20. 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
