FDA News Digest
March 24, 2008
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IN THIS WEEK’S ISSUE
» News
— FDA Approves New Medical Adhesive to Treat Burn Patients
» Safety Alerts/Recalls
» Consumer Health Information
FDA Approves New Medical Adhesive to Treat Burn Patients
FDA has approved Artiss, a medical adhesive for use in attaching skin grafts onto burn patients. The product contains fibrinogen and thrombin, two proteins essential in the clotting of blood. Artiss differs from other similar sealants because it contains a lower concentration of thrombin, allowing surgeons time to position skin grafts over burns before the graft begins to adhere to the skin.
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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SAFETY ALERTS/RECALLS
Safety Alert:
Following reports of 50 illnesses in 16 states, FDA has issued an import alert regarding cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer. Based on current information, fruit from this company appears to be associated with a Salmonella outbreak in the United States and Canada. The import alert advises FDA field offices that cantaloupes shipped to the United States by this company are to be detained. FDA also has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove any cantaloupes that come from this company.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01808.html
Food Recalls:
› Acme 4-pack Cinnamon Rolls with Icing (sold in New Jersey, Pennsylvania, Delaware, and Maryland)
Reason for recall: milk component not declared on label
http://www.fda.gov/oc/po/firmrecalls/acme03_08.html
› Certain lots of Bass Pro Shops Uncle Buck’s Light ‘n Krispy Original (8 oz. pouches and 22-oz. size) and Light ‘n Krispy Hot & Spicy (22-oz. size) fish batter mixes; sold in Bass Pro Shops nationwide
Reason for recall: milk component not declared on label
http://www.fda.gov/oc/po/firmrecalls/williams03_08.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 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
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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UPCOMING PUBLIC MEETINGS
March 25 — Pediatric Advisory Committee
Under discussion: adverse events reports for several drugs
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1296.htm
April 1-2 — Anti-Infective Drugs Advisory Committee
Under discussion: product development and clinical trial design for community-acquired pneumonia
Location: Beltsville , Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-814.htm
April 4 — Quality System Regulation Educational Forum on Design Controls, a public workshop for regulated industry, especially small businesses
Location: Dallas, Texas
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20077.htm
April 7-8 — QT and Arrhythmia Issues in Drug Development
Under discussion: development of pharmaceutical agents, as well as challenges and solutions
Location: Bethesda, Md.
For a complete list of meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
CONSUMER HEALTH INFORMATION
Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:
› Getting Up to Date on Glucose Meters
http://www.fda.gov/consumer/updates/glucosemeters110107.html
› FDA’s Strategic Plan: Charting Our Course for the Future
http://www.fda.gov/consumer/updates/strategicplan022908.html
To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html
Eat Know How 