FDA News Digest June 2, 2003 ______________________________________________________________ Study Doesn't Warrant Changes in Use of Estrogen/Progestin, FDA Says New research that links combined estrogen/progestin therapy to an increased risk of dementia in some women does not at this time dictate any changes to the approved uses of these drugs, FDA says. The agency is reviewing the research results and will determine if labeling should be updated to inform women and health care providers about these possible side effects. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01226.html ______________________________________________________________ FDA, NCI Plan Program to Help Speed Development of New Cancer Drugs FDA and the National Cancer Institute plan to share resources in a program that will help speed development and delivery of new cancer drugs. FDA Commissioner Mark B. McClellan, M.D., says the agreement comes "when the opportunities to reduce the burden of cancer are greater than ever." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00912.html ______________________________________________________________ FDA, Customs to Streamline Collection of Information on Food Imports FDA and the Bureau of Customs and Border Protection will allow food importers to provide new required "prior notice" information to both agencies under a streamlined system, minimizing the impact of complying with provisions of the Bioterrorism Act of 2002. Food makes up nearly 20 percent of all imports into the United States. The Bioterrorism Act is intended to reduce the ability of terrorists to contaminate imported foods. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00911.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Best Life "Viga" tablets (unlabeled sildenafil) http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#viga Shaw's Chocolate Grahams (excessive sodium metabisulfite) http://www.fda.gov/oc/po/firmrecalls/shaws05_03.html Calders Dairy Half and Half (inadequate processing) http://www.fda.gov/oc/po/firmrecalls/calders05_03.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be June 9. 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
