FDA News Digest for November 6, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

November 6, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Restaurant Tomatoes Linked to Salmonella Outbreak

    -- Generic Version of Bacterial Vaginosis Drug Approved

    -- Latest 'Patient Safety News' Video Available Online

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Restaurant Tomatoes Linked to Salmonella Outbreak

A federal and state investigation has shown that restaurant tomatoes tainted with Salmonella bacteria were responsible for an illness outbreak that affected 21 states and sickened 183 people. FDA says illness cases peaked in late September and that no more contaminated tomatoes are  in circulation.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01504.html

-- Food safety tips: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01503.html

 

Generic Version of Bacterial Vaginosis Drug Approved

FDA has approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a widely used antibacterial drug that treats bacterial vaginosis. Used for filling more than half of all prescriptions, generic drugs can save consumers money because they typically cost a fraction of the price of brand-name drugs.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01501.html

 

Latest 'Patient Safety News' Video Available Online

FDA has posted the latest edition of "Patient Safety News," a free 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.

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

Food Recalls:

 

Sara Lee Premium White Hamburger Buns, 12 oz. size (North Carolina and South Carolina only)

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/saralee10_06.html

 

Krisp-Pak brand packaged fresh-cut fruit, various sizes (with expiration dates on or before 11/9/06)

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/krisppak11_06.html

 

Boston Salads' Cole Slaw Salad, various sizes (with "sell by" dates of 11/9/06 or 11/11/06)

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/bostonsalads11_06.html

 

Maizteca Mexican Bread, 1.5 lb. size

   Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/maizteca10_06.html

 

Archway Classic Oatmeal Big Batch Homestyle Cookies (recall limited to 633 packages)

    Reason for recall: undeclared allergens (especially walnuts)

http://www.fda.gov/oc/po/firmrecalls/archway11_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

Nov. 15-16 -- Detroit District Workshop on FDA Clinical Trial Statuary and Regulatory Requirements

    Under discussion: FDA regulation of clinical research conduct, informed consent requirements, other topics

    Location: Indianapolis

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13114.htm

 

Nov. 16 -- Immunology Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for diagnostic test for metastatic breast cancer

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-16319.htm

 

Nov. 29 -- Arthritis Advisory Committee

    Under discussion: pending application for drug to treat juvenile rheumatoid arthritis

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8787.htm

 

Jan. 9 -- Public Workshop on Marketed Unapproved Drugs

    Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products

    Location: Rockville, Md.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html

-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.htm

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

 

What is human papillomavirus (HPV)?

HPV is a sexually transmitted virus that can be passed on through genital contact or by skin-to-skin contact. At least 50 percent of people who have had sex will have HPV at some time in their lives.

 

Most people don't have any signs of infection, and HPV may go away on its own. Both men and women may get the virus -- and pass it on -- without knowing it.

 

There is no cure for the virus infection itself, but there are treatments for the health problems that HPV can cause such as genital warts, cervical changes, and cervical cancer.

 

A recently approved vaccine called Gardasil creates resistance to four types of HPV but is not a treatment for an existing HPV infection.  

 

For more information on HPV, see http://www.fda.gov/womens/getthefacts/hpv.html.

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