FDA News Digest October 20, 2003 ______________________________________________________________ First Drug Approved for Moderate-to-Severe Alzheimer's Disease FDA has approved Namenda (memantine), to treat moderate-to-severe Alzheimer's disease. Previous Alzheimer's therapies have been intended for treating less severely affected patients. The drug helps treat Alzheimer's in some patients, but there is no evidence that it affects the underlying cause of the disease. About 4.5 million Americans have Alzheimer's disease, a degenerative condition that affects memory, judgment, and the ability to reason. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00961.html _______________________________________________________________ Electronic Registration System Debuts to Boost Security in Food Supply To help bolster the safety and security of America's food supply, FDA has unveiled a new online system that food facilities can use to register with the agency. This system will help with quick identification of food processors involved in any deliberate or accidental food contamination. All foreign and domestic food facilities must register with FDA by Dec. 12 as part of the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00960.html More information: http://www.fda.gov/oc/bioterrorism/furls/ ______________________________________________________________ Proposal Aims to Ensure Safety, Effectiveness of Unapproved Medicines FDA is proposing steps to ensure the safety and effectiveness of certain unapproved, but widely marketed, medicines. These drugs were developed and marketed before modern standards for drug approval were established. These drugs have continued to be prescribed by some health professionals because some people believe they are safe and effective for certain uses. Some of these drugs, however, have been shown to be ineffective and even dangerous. FDA is proposing that adequate scientific data be developed for all these drugs. Press Release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00962.html Draft Compliance Policy Guide: http://www.fda.gov/cder/guidance/5704dft.pdf Questions and Answers: http://www.fda.gov/cder/compliance/CPG_QandA.htm ______________________________________________________________ Joint Agency Health Initiative to Focus on Older Hispanic Americans FDA and the Administration on Aging are collaborating on a program to communicate important health information to older Hispanic Americans and their families. The two agencies will cultivate and expand partnerships with national Hispanic organizations, Hispanic media, and other private organizations. The population of Hispanics over age 65 is projected to reach 13 million by 2050. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00959.html ______________________________________________________________ Rumors of Flu Vaccine Recall are False, say FDA and CDC Rumors that a contaminated lot of influenza vaccine has been recalled are false, according to FDA and the U.S. Centers for Disease Control and Prevention. No contamination of any flu vaccine has occurred anywhere in the United States and FDA has not recalled any flu vaccine, the agencies say. http://www.fda.gov/cber/flu/flurclstmt.htm ______________________________________________________________ RECALL The following product is being recalled for the reason shown. Go to the linked page for more information. Ashe County Mexican-Style Quesco Fresco cheese (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/ashecounty10_03.html ______________________________________________________________ PUBLIC MEETINGS Oct. 23 -- Public Meeting on Obesity; Bethesda, Md. http://www.fda.gov/oc/opacom/hottopics/obesity.html Oct. 23-24 -- Workshop on Counterterrorism Products Regulated by the FDA Center for Biologics Evaluation and Research; Bethesda, Md. http://www.fda.gov/cber/meetings/cntrtrrsm102303.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 October 27. 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
