January 9, 2006
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IN THIS WEEK'S ISSUE
» News
-- '06 Events Set to Commemorate FDA's 100th Anniversary
-- Web Site Answers Questions about Medical Device Recalls
-- Latest 'Patient Safety News' Video Available Online
»
Question of the
Week
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'06 Events Set to Commemorate FDA's 100th Anniversary
In celebration of its 100th anniversary this year, FDA will be holding events throughout 2006 both in the Washington, D.C., area and around the country. Officials unveiled the agency's centennial banner Jan. 4 in Atlanta. Other activities will salute FDA's accomplishments and inspire future efforts to advance science, innovation, and public health.
-- List of centennial activities: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01292.html
-- FDA Centennial Web site: http://www.fda.gov/centennial/default.htm
Web Site Answers Questions about Medical Device Recalls
What exactly is involved when medical devices are recalled from the market? What kinds of recalls are there? Should consumers stop using devices that are recalled? These questions and many others are answered on the FDA Web site "Learn About Medical Device Recalls." The site is written in an easy-to-understand format for consumers, and it includes links to regulatory information for device industry users.
http://www.fda.gov/cdrh/recalls/learn.html
Latest 'Patient Safety News' Video Available Online
FDA has posted the January edition of "Patient Safety News," a Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls. Topics included in this edition include warnings about certain bronchodilators and blood glucose meters.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
To view an archive of past
FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html.
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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RECALLS/SAFETY
ALERTS
Recalls:
Trader Joe's Gourmet Chocolate Fudge; 8-oz. size
Reason for recall: undeclared walnuts
http://www.fda.gov/oc/po/firmrecalls/traderjoes01_06.html
Fisher brand Deluxe Mixed Nuts (w/No Peanuts); 32-oz. size
Reason for recall: undeclared peanuts
http://www.fda.gov/oc/po/firmrecalls/sanfilippo01_06.html
Arnold brand Country Classic Oat Bran Bread
Reason for recall: undeclared walnuts and hazelnuts
http://www.fda.gov/oc/po/firmrecalls/arnold01_06.html
Publix Cinnamon Raisin Bagels; 4-pack
Reason for recall: undeclared eggs
http://www.fda.gov/oc/po/firmrecalls/publix01_06.html
Scobee Grill Double Chili Dogs with Cheese
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/scobee12_05.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
Jan. 20 -- Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)
Under discussion: regulation and approval of circulatory support devices used for temporary support in pediatric patients
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-24271.htm
Jan. 23 -- Joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee
Under discussion: pending application for over-the-counter use of the prescription weight-loss drug Orlistat
Location:
http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012306.html
Jan. 24 -- Joint meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee
Under discussion: the continuing need to designate over-the-counter epinephrine metered-dose inhalers as an essential use of ozone-depleting substances
Location:
http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html
Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative Public Workshop and Vendor Display
Under discussion: adoption of radio-frequency identification in the U.S. medicine supply chain to combat counterfeit products
http://www.fda.gov/rfidmeeting.html
For a list of FDA meetings,
seminars, and other public events, go to
Common symptoms of
foodborne illness include diarrhea, abdominal cramps, fever, headache, vomiting, severe exhaustion,
and sometimes blood or pus in the stool. However, symptoms will vary according
to the type of bacteria and the amount eaten.
In rare instances, symptoms
may come on as early as a half hour after eating contaminated food, but
typically they do not develop for several days or even weeks. Symptoms of viral
or parasitic illnesses may not appear for several weeks after exposure. Symptoms
usually last only a day or two, but in some cases they can persist a week to 10
days. For most healthy people, foodborne illnesses are neither long-lasting nor
life-threatening. However, they can be severe in the very young, the very old,
and people with certain diseases and conditions.
These include:
When symptoms are severe, see a doctor or get emergency help. This is especially important for those who are most vulnerable. Even in mild cases of foodborne illness, drink plenty of liquids to replace fluids lost through vomiting and diarrhea.
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