FDA News Digest for March 27, 2006

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FDA News Digest     

March 27, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Statement Issued on Review Time for MS Drug Tysabri

    -- Web Pages Give Background on Recently Approved Devices

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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Statement Issued on Review Time for MS Drug Tysabri
The maker of the suspended multiple sclerosis drug Tysabri has announced that FDA is extending the period by up to 90 days for reviewing the application to reintroduce the drug. The extension will give FDA time to review what the agency calls a "major amendment" to the pending application.
 
Web Pages Give Background on Recently Approved Devices
FDA's Center for Devices and Radiological Health has posted online consumer information on three recently approved medical devices:
    *  LUMA Cervical Imaging System
    Intended use: helps doctors identify areas on the cervix that may have precancerous cells
    *  StarClose Vascular Closure System 
    Intended use: to close puncture site in femoral artery following cardiac catheterization
   *  STAN S31 Fetal Heart Monitor
    Intended use: to determine in childbirth if labor should continue or if intervention is needed for delivery
 

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

Food Recalls:

 

Sam's Choice Belgian Milk Chocolate Bars; 7-oz. size

    Reason for recall: undeclared almonds

http://www.fda.gov/oc/po/firmrecalls/brach03_06.html

 

Certain lots of North Country Spring Water Ltd. bottled water products (distributed under various brand names)

    Reason for recall: possible bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/northcountry03_06.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 27-28 -- Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a device to prevent post-surgical adhesion

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12524dd03272806.html 

 

March 29 -- Workshop on hand-held, Doppler ultrasound prenatal listening devices

    Under discussion: risks and benefits of selling these devices over the counter

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E5-7643.htm

 

April 5 -- Workshop on food labeling

    Under discussion: FDA food-labeling regulations; especially of interest to small businesses

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E5-8225.htm

 

April 18-20 -- 2006 FDA Science Forum; includes sessions on drug safety, obesity, avian flu, and non-invasive medical devices. Also planned is a free public session April 18 called "Ask FDA," in which agency scientists will answer questions from consumers about products FDA oversees.

    Location: Washington, D.C.

http://www.fda.gov/scienceforum

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

I've heard that antibiotics shouldn't be used to treat viral illnesses like colds and the flu. What should they be used for?
Antibiotics are used to treat illnesses caused by bacteria. Examples include strep throat, tuberculosis and many types of pneumonia.
Taking antibiotics when they aren't needed contributes to the serious problem of antibiotic resistance. This is when bacteria have become resistant and cannot be killed by antibiotics. If the antibiotic misuse continues, some recurring infections ultimately may have to be treated with different and stronger antibiotics, leading to the possibility that eventually no antibiotic will be effective in killing the bacteria.

There are many over-the-counter products available to treat the symptoms of viral infections. These include cough suppressants to help control coughing and decongestants to help relieve a stuffy nose. Read the label and ask your pharmacist or doctor if you have any questions about which will work best for you.

To learn more about antibiotic resistance, see http://www.fda.gov/oc/opacom/hottopics/anti_resist.html.

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