Note: The FDA website will move to a new server between 8 p.m., May 23, and noon, May 24, EST. The move should not cause problems in accessing the site, but if you have difficulties, please try again later. The move will not change how to reach the FDA website. It still will be found at www.fda.gov. FDA News Digest May 19, 2003 ______________________________________________________________ New Type of Drug Approved to Treat Bone Marrow Cancer FDA has approved Velcade (bortezomib) to treat multiple myeloma, a cancer of the bone marrow. The injectable drug was approved in less than four months under the agency's accelerated approval program, which makes promising products for serious or life-threatening diseases available earlier in the drug development process. Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma, affecting about 45,000 people in the United States. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00905.html Velcade information page: http://www.fda.gov/cder/drug/infopage/velcade/default.htm ______________________________________________________________ FDA OKs Rapid Test for Life-Threatening Fungal Infection FDA has cleared for marketing the first rapid laboratory test for aspergillus, an infection that occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy. The test will allow doctors to diagnose the potentially deadly infection quicker and begin treatment sooner. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00907.html ______________________________________________________________ Lower Cost Implantable Defibrillator Approved FDA has approved a new implantable cardioverter defibrillator (ICD) that is about half the price of similar devices on the market. ICDs are surgically implanted into the chest to sense heart function in people at risk of dying from sudden cardiac arrest. They automatically deliver an electrical shock when needed to restore normal heart rhythms. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00906.html ______________________________________________________________ FDA Issues Draft Guidance on Using Deer and Elk Material in Animal Feed FDA has issued draft guidance describing the agency's recommendations about the use in animal feed of any material from deer and elk that is positive, or at high risk, for chronic wasting disease (CWD). CWD is a neurological (brain) disorder that is in the same family as bovine spongiform encephalopathy (BSE, or "mad cow disease"). FDA is asking for comments on the guidance by June 16. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01220.html ______________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: Hannaford Blueberry Muffin Mix (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/hannaford05_03.html Leonard Novelty Bakery No Cholesterol assorted 16-oz. Packaged Cookies (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/leonard05_03.html Gar Shing Choco Chips cookies (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/GarShing05_03.html ______________________________________________________________ PUBLIC MEETINGS Video of May 7 Bioterrorism Act Meeting Available Online A video recording of a May 7 FDA public meeting and satellite broadcast that discussed two provisions of the Bioterrorism Act of 2002 is available on FDA's website. The two-hour recording is available in English, Spanish, or French. FDA held the meeting to help explain proposed regulations regarding the administrative detention of food that may pose a risk to public health and records maintenance among food companies. http://www.cfsan.fda.gov/%7Ecomm/vltbtac2.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ RECENT TESTIMONY Tissue Banks: The Danger of Tainted Tissues and the Need for Federal Regulation -- FDA Center for Biologics Evaluation and Research Director Jesse L. Goodman, M.D., before the Senate Committee on Governmental Affairs (May 14) http://www.fda.gov/ola/2003/tissuebanks0514.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be May 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
