FDA News Digest for July 16, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

July 16, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  LASIK Device OK'd to Correct One Eye for Far Vison, Other for Near

    --  New Test Approved for Detecting Breast Cancer That Has Spread

    --  Web Pages Give Background on Newly Approved Medical Devices

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

LASIK Device OK'd to Correct One Eye for Far Vison, Other for Near

FDA has approved CustomVue Monovision LASIK, the first device of its kind for treating one eye to see far away objects and the other eye for close-up vision. The approval expands vision correction options for nearsighted adults who also have trouble focusing on close-up objects. The device may reduce the need for reading glasses in some people over 40.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01665.html

 

New Test Approved for Detecting Breast Cancer That Has Spread

FDA has approved the GeneSearch BLN Assay, the first molecular-based laboratory test for detecting whether breast cancer has spread to nearby lymph nodes. The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with breast cancer that has spread (metastasized).

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01667.html

 

Web Pages Give Background on Newly Approved Medical Devices

FDA has posted online consumer information for three recently approved products:

    »  INRange Remote Medication Management System

     Intended use: to aid in control of delivery of prescription medicines to patients in an outpatient setting

    More information: http://www.fda.gov/cdrh/mda/docs/k051338.html

    »  Novation Ceramic Articulation Hip System

    Intended use: to completely replace a diseased or damaged hip joint 

    More information: http://www.fda.gov/cdrh/mda/docs/p050039.html

    »  STS-7 Continuous Glucose Monitoring System 

    Intended use: to help detect patterns in glucose (sugar) levels in diabetics aged 18 and older

    More information: http://www.fda.gov/cdrh/mda/docs/P050012S001.html

 

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

Toothpaste Recall:

 

›  FDA has a special page that lists the latest information on brands of toothpaste being recalled due to the presence of a poisonous chemical, diethylene glycol. 

http://www.fda.gov/oc/opacom/hottopics/toothpaste.html

 

Food Recalls:

 

›  Gerber Organic Rice and Gerber Organic Oatmeal, 8 oz. boxes

    Reason for recall: potential choking hazard

http://www.fda.gov/oc/po/firmrecalls/gerber07_07.html

›  Market Basket Complete Pancake & Waffle Mix, 32 oz. cartons

    Reason for recall: milk not declared on label

http://www.fda.gov/oc/po/firmrecalls/karlin07_07.html

›  Sun Kee Brand Dried Sweet Potato, 12 oz. size

     Reason for recall: sulfites not declared on label 

http://www.fda.gov/oc/po/firmrecalls/prosperityresources07_07.html

 

Safety Alert:

 

›  Following confirmation that a strain of Salmonella bacteria found in Veggie Booty is responsible for a disease outbreak between March and June 2007, FDA continues to advise consumers not to eat Veggie Booty and to throw away any of the product they have. The agency also is advising consumers not to eat Super Veggie Tings Crunchy Corn Sticks, which also may be contaminated.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01666.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

July 17 -- Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for cervical disc prosthesis

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-10267.htm

 

July 24 -- Oncologic Drugs Advisory Committee

    Under discussion: two pending drug approval applications

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11496.htm

 

July 26 -- Cellular, Tissue, and Gene Therapies Advisory Committee

    Under discussion: updates on two research programs

    Location: Bethesda, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11728.htm

 

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

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

 

 

QUESTION OF THE WEEK

 

What's the difference between viruses and bacteria?

There are many differences. Viruses are the smallest and simplest life form known. They are 10 to 100 times smaller than bacteria. The biggest difference between viruses and bacteria is that viruses must have a living host -- like a plant or animal -- to multiply, while most bacteria can grow on non-living surfaces.

 

Also, unlike bacteria, which attack the body like soldiers mounting a battle, viruses are guerilla fighters. They don't attack so much as infiltrate. They literally invade human cells and turn the cell's genetic material from its normal function to producing the virus itself.

 

In addition, bacteria carry all the machinery needed for their growth and multiplication, while viruses carry mainly information -- DNA or RNA, for example. Viruses harness the host cell's machinery to reproduce. In a sense, viruses are not truly "living," but are essentially information floating around until encountering a suitable living host.

 

For more information, see http://www.cfsan.fda.gov/~dms/a2z-uvw.html#virus.

 

 

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