FDA News Digest for February 5, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

February 5, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FY' 08 Budget Request Includes Increases in Food, Drug Safety

    -- FDA Responds to Institute's Drug Safety Recommendations

    -- Biological Product Approved to Treat Bleeding Disorder

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FY' 08 Budget Request Includes Increases in Food, Drug Safety

FDA is requesting $2.1 billion as part of the president's fiscal year 2008 budget, an increase of more than 5 percent over last year's budget request. Included in the budget are funding increases for key FDA programs such as food, drug, and medical device safety and review of generic drugs.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01554.html

-- FDA budget summary: http://www.fda.gov/oc/oms/ofm/budget/2008/summary.html

 

FDA Responds to Institute's Drug Safety Recommendations

In response to a 2006 report by the Institute of Medicine that offers recommendations on how FDA can improve its drug safety efforts, the agency has put forth an action plan. Included are three key efforts: strengthening the science that supports drug safety, improving communications among those promoting safe medical products use, and improving operations and management.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01551.html

-- Fact sheet: http://www.fda.gov/oc/factsheets/drugsafety-iom.html 

 

Biological Product Approved to Treat Bleeding Disorder

FDA has approved the first biological product for patients with von Willebrand disease, a bleeding disorder, who are undergoing surgery or invasive procedures. FDA calls the new product "a proven preventive therapy that can make needed surgery possible and safer." Von Willebrand disease affects about one percent of the U.S. population, many of whom do not need treatment to stop bleeding.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01553.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 Recalls:

 

Betsy Ross Brand Chocolate Donuts and Old Fashioned Donuts; 12-oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/usbakery01_07.html

 

Major Egg product; vanilla, chocolate and strawberry flavors; 2.2 lb. size

    Reason for recall: undeclared dairy content

http://www.fda.gov/oc/po/firmrecalls/qfl01_07.html

 

Certain lots of Knorr Chicken Flavor Bouillon cubes

    Reason for recall: undeclared fish content

http://www.fda.gov/oc/po/firmrecalls/knorr02_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

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

 

Feb. 9 -- Medical Devices 101: An Educational Forum

    Under discussion: FDA's medical device requirements for entrepreneurs, startup companies, and small businesses.

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-92.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 should I know if I'm planning to buy a laser pointer over the Internet?

 

FDA warns consumers that some laser pointers being sold on the Internet may not meet federal safety requirements and should not be available for purchase by the general public. In some cases, these products are overpowered and may be unsafe if not used responsibly. In other cases, products are intended for use only by licensed medical professionals, trained operators, or other approved users.

 

FDA is concerned about reports of laser pointers directed at aircraft -- a potentially hazardous situation. The agency is particularly concerned about the increased availability of overpowered green laser pointers, which may have been modified to emit more radiation than the manufacturer's original product.

 

The agency is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent unsafe products from being sold in the United States. Illegal products may be refused entry into the country, returned to the seller, or destroyed.

FDA urges you to be cautious when buying laser products online. You may unknowingly purchase an illegal laser product or may lose your money if the illegal product is refused entry into the U.S. or destroyed.

For more information on buying laser products online, see http://www.fda.gov/cdrh/comp/internetlasers.html.

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HOW'S YOUR KNOWLEDGE of health topics such as vaccines

and food additives? Find out by taking our FDA Consumer quiz

at http://www.fda.gov/fdac/quiz/onlinequiz33_js.html.

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