FDA News Digest May 3, 2004 ________________________________________________________________ -- Pancreatic Extract Makers Required to Submit Marketing Applications -- FDA Proposal Would Provide Additional Safeguards for Imported Food -- Risk Information Updated on Irritable Bowel Syndrome Drug Zelnorm -- Report Highlights FDA Biological Products Activities, Initiatives -- Recalls/Market Withdrawals -- FDA Congressional Testimony -- Public Meetings ________________________________________________________________ Pancreatic Extract Makers Required to Submit Marketing Applications FDA has notified manufacturers of pancreatic extract products -- used to treat conditions such as chronic pancreatitis and cystic fibrosis -- that these drugs must get FDA approval within the next four years in order to stay on the market. FDA took the action after its review of current pancreatic extract products showed substantial potency variations, a situation the agency called "unacceptable." These products have been available because of their established use as therapy to treat conditions associated with pancreatic insufficiency. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01058.html Questions and answers: http://www.fda.gov/cder/drug/infopage/pancreatic_drugs/pancreatic_QA.htm FDA Proposal Would Provide Additional Safeguards for Imported Food FDA is proposing a rule that would help ensure the integrity and scientific validity of imported food sampling data from private analytical laboratories. FDA estimates that food importers hire more than 100 private laboratories to generate analytical data to support claims that imported foods comply with U.S. laws. The agency's proposal aims to keep imported food sampling and analysis free of unauthorized interference and to deter manipulation or substitution of tested products. http://www.fda.gov/bbs/topics/news/2004/NEW01057.html Risk Information Updated on Irritable Bowel Syndrome Drug Zelnorm Revised risk information will be added to the labeling of the drug Zelnorm (tageserod meleate), a short-term treatment for women with irritable bowel syndrome whose primary symptom is constipation. Revisions include a warning about the consequences of diarrhea associated with the drug and a precaution about ischemic colitis and other forms of intestinal ischemia (such as reduced blood flow to the intestines). http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01285.html Report Highlights FDA Biological Products Activities, Initiatives Addressing regulatory challenges related to biological products such as blood, human tissue, and vaccines is the focus of an annual report released by FDA's Center for Biologics Evaluation and Research (CBER). The report highlights CBER's activities during fiscal year 2003 and takes a look at key initiatives for 2004, which include improving biological product review, boosting human tissue safety, and helping ensure the availability of needed products in the event of a terrorist attack. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01286.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Lucerne Chocolate Ice Cream; 1/2-gal. size (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/safeway04_04.html Premium Purity Moose Tracks (pint, half-gallon, and 3-gallon sizes) and After Dinner Mint (half-gallon size) ice cream (undeclared egg) http://www.fda.gov/oc/po/firmrecalls/purity04_04.html Publix Bakery Glazed Almond One Half Crème Cakes (may be mislabeled and contain undeclared almonds) http://www.fda.gov/oc/po/firmrecalls/publix04_04.html For a listing 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 ________________________________________________________________ FDA CONGRESSIONAL TESTIMONY FDA Associate Commissioner for Policy and Planning William K. Hubbard; before a joint hearing of the Senate Subcommittee on Health Care and Subcommittee on International Trade; subject: health and safety issues related to importation of pharmaceutical products into the United States (April 27) http://www.fda.gov/ola/2004/importeddrugs0427.html To view the text of past FDA testimony, go to http://www.fda.gov/ola/listing.html. ________________________________________________________________ PUBLIC MEETINGS May 13-14 -- FDA/NIH Joint Symposium on Diabetes will examine the current state of diabetes prevention and treatment (Bethesda, Md.) http://www.niddk.nih.gov/fund/other/FDA-NIH/index.htm May 18-19 -- FDA Science Forum will showcase FDA's scientific achievements, present topics of interest to FDA and its constituents, and promote internal and external scientific collaborations. (Washington, D.C.) http://www.cfsan.fda.gov/%7Efrf/sxsfin04.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 May 10. 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
