FDA News Digest for January 16, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

January 16, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Proposal Would Strengthen Drug Safety Under User Fee Renewal

    -- FDA, States Moving In on Cause of Midwest E. coli Illness

    -- Proposal: Certain Cattle Material Would be Barred from Medical Products

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Proposal Would Strengthen Drug Safety Under User Fee Renewal

FDA has proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee Act which, if adopted, would broaden and upgrade the agency's drug safety program. The proposed changes also would boost resources for review of television drug advertising. To accomplish these goals, FDA is recommending an increase in user fee collections of nearly $88 million.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01544.html

 

FDA, States Moving In on Cause of Midwest E. coli Illness

FDA and officials in four states are getting closer to identifying the source of E. coli O157:H7 contamination that sickened 81 people late last year who ate at Taco John's restaurants in Iowa and Minnesota. They were able to match the DNA of bacteria associated with the outbreak to bacteria in samples gathered from dairy farms near a lettuce-growing area in central California.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01546.html

 

Proposal: Certain Cattle Material Would be Barred from Medical Products

FDA is proposing to limit the materials used in some medical products to keep them free of the agent thought to cause mad cow disease (bovine spongiform encephalopathy, or BSE). The move is the latest in a series of precautions to bar material known to have the highest concentration of the BSE agent in infected cattle.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01545.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

Food Recall:

 

Home Special Health Soup Recipe (Dry Mix), 5.3 oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/ho01_07.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. 23-24 -- Reproductive Health Drugs Advisory Committee

    Under discussion: oral and non-oral hormonal contraceptives

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21949.htm

 

Jan. 26 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-20552.htm

 

Feb. 7-8 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: various aspects of establishing and conducting clinical trials including ethics, informed consent, and FDA's role

    Location: San Diego

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21138.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 factors increase the risk of getting diabetes?

 

Although researchers don't fully understand why some people get diabetes and others don't, it is clear that certain factors increase your risk. You are at increased risk for having diabetes if:

• Your mother, father, sister, or brother has diabetes;
• You are African American, Hispanic American/Latino, American Indian, Native Alaskan, Asian American, or Pacific Islander;
• You have high blood pressure (at or above 130/80);
• You have a history of diabetes during pregnancy (gestational diabetes) or gave birth to a baby weighing more than nine pounds at birth;
• You are overweight or obese;
• You are inactive or have a sedentary lifestyle; or
• You are more than 45 years old.

If you have one or more of these risk factors, even if you are experiencing no symptoms, your doctor may want to test you for diabetes.

 

For more information about diabetes, see http://www.fda.gov/diabetes/.

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