FDA News Digest August 30, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- New Test Can Help Screen Newborns for Several Inherited Diseases -- FDA Finds Poor-Quality Mammograms at Florida Health Facility -- Wholesalers Plead Guilty for Not Providing Drug 'Pedigree' Information -- Recalls/Market Withdrawals -- Recent Speeches -- Public Meetings ____________________________________________________________ New Test Can Help Screen Newborns for Several Inherited Diseases FDA has cleared for marketing a new laboratory blood test that can help doctors screen newborn infants for a variety of inherited diseases. Performed using a blood sample taken with a heel stick, the test measures substances that, when found in abnormally high amounts, can indicate rare diseases such as phenylketonuria, isovaleric acidemia, and homocystinuria. When found early, the effects of these diseases can be reduced, with an improved long-term outcome and better quality of life. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01308.html FDA Finds Poor-Quality Mammograms at Florida Health Facility Following an FDA inspection that uncovered poor-quality mammograms that were done at the Hialeah, Fla.-based Ecumed Health Group facility, the agency has notified patients who used the facility that they may need to have their mammograms re-evaluated and possibly repeated. FDA's review of a sample of Ecumed's mammograms showed that the facility failed to meet standards for image quality the agency requires under provisions of a 1992 mammography quality law. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01307.html Spanish version: http://www.fda.gov/bbs/topics/answers/spanish/span01307.html Wholesalers Plead Guilty for Not Providing Drug 'Pedigree' Information Two Cincinnati prescription drug wholesalers have pleaded guilty in U.S. district court to misdemeanor charges that they failed to provide to their customers required statements commonly known as drug "pedigrees." These are documents that give the history and background of drugs being distributed. Both companies -- RxBazaar Inc. and FPP Distribution Inc.-- were sentenced to five years probation and a $100,000 fine. http://www.fda.gov/bbs/topics/news/2004/NEW01109.html ____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked pages for more information. Nellcor Puritan Bennett "CapnoProbes" (suspected link to bacterial infections in 11 children) http://www.fda.gov/bbs/topics/news/2004/NEW01108.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Mayo Alliance for Clinical Trials Conference (Aug. 26) http://www.fda.gov/oc/speeches/2004/mayo0826.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ PUBLIC MEETINGS Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html 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 September 7. 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
