FDA News Digest for August 7, 2006

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FDA News Digest     

August 7, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- FDA OKs Vaccines to be Made for Upcoming Flu Season

    -- New Method Developed to Identify Hoax Bioterror Incidents

    -- Latest 'Patient Safety News' Video Available Free Online

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS
 

FDA OKs Vaccines to be Made for Upcoming Flu Season

FDA has approved flu vaccines from four manufacturers that include new virus strains judged likely to cause flu in the Northern Hemisphere in the upcoming flu season. FDA says the flu vaccine is the best way to prevent the disease. Each year, about 200,000 people are hospitalized and 36,000 die from flu complications in the United States.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01423.html

 

New Method Developed to Identify Hoax Bioterror Incidents

FDA researchers are developing a quick, cost-effective way to distinguish potential hoax materials from real bioterror agents. The new method offers a significant advantage over other available tests, which are more expensive and time consuming. The research was conducted at FDA's National Center for Toxicological Research.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01424.html

 

Latest 'Patient Safety News' Video Available Free 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

Drug Recalls:
 
WellPatch Cough & Cold Soothing Vapor Pads
    Reason for recall: child could remove pad and chew or otherwise ingest its contents

http://www.fda.gov/oc/po/firmrecalls/mentholatum07_06.html

 
Ultravist Injection 370 mgl/mL (iopromide injection), an x-ray contrast agent
    Reason for recall: particulate material, crystallization may be present

http://www.fda.gov/oc/po/firmrecalls/berlex207_06.html

 
Food Recall: 
 
Classic Salads' Baby Spinach (10 oz., and 2 and 4 lb. sizes) and Spring Mix (1.5, 3, and 4 lb.sizes)
    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/classicsalad07_06.html

 

Safety Alerts:

 

FDA is warning consumers to avoid eating raw oysters harvested in the Pacific Northwest following reports of an unusual increase in illnesses associated with naturally occurring bacteria. For the time being, the agency is advising that oysters from this region be cooked thoroughly before eating.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01422.html

 

The Federal Trade Commission is urging consumers to be skeptical about at-home genetic tests that are touted to screen for diseases and provide a basis for choosing a particular diet, lifestyle, or medication. These types of tests, says FDA, should be performed in a specialized laboratory, and the results should be interpreted by a trained professional.

http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.htm

 


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.

 

Note: FDA has created a free e-mail list that allows you to receive press releases about recalls of FDA-regulated products. The list covers only Class 1 (life-threatening) recalls. To sign up, go to http://list.nih.gov/cgi-bin/wa?SUBED1=fda-recalls-l&A=1

 

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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CONGRESSIONAL TESTIMONY

Aug. 1 -- FDA Acting Commissioner Andrew C. von Eschenbach, M.D., appeared before the Senate Health, Education, Labor, and Pensions Committee to deliver testimony as part of his confirmation hearing for appointment as FDA commissioner.

http://www.fda.gov/ola/2006/confirmation0801.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

 

Aug. 23-24 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: industry and FDA perspectives on proper conduct of FDA-regulated clinical trials

    Location: Brooklyn Park, Minn.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8896.htm

 

Aug. 24-25 -- General and Plastic Surgery Devices Advisory Committee

    Under discussion: pending review of injectable material proposed to restore soft tissue facial contours

    Location: Gaithersburg, Md.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=628

 

Aug. 29 -- Reproductive Health Drugs Advisory Committee

    Under discussion: pending review of a drug to prevent preterm delivery in women with history of preterm delivery

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11538.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

 

Are there any foods that are exempt from federal nutrition labeling requirements? 

Yes, under the Nutrition Labeling and Education Act of 1990, these foods are exempt from nutrition labeling:

»  food served for immediate consumption, such as that served in hospital cafeterias and airplanes, and that sold by food service vendors      (such as mall cookie counters, sidewalk vendors and vending machines);

»  ready-to-eat food that is not for immediate consumption but is prepared primarily on site (such as bakery, deli and candy store items);

»  food shipped in bulk, as long as it is not for sale in that form to consumers;

»  medical foods, such as those used to address the nutritional needs of patients with certain diseases;

»  plain coffee and tea, some spices, and other foods that contain no significant amounts of any nutrients.

 

For more on food labeling, see http://www.cfsan.fda.gov/label.html. 

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