FDA News Digest for April 16, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

April 16, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Makes Recommendations for Reauthorizing Device User Fees

    -- Antibiotic Ointment Approved for Treating Bacterial Skin Infection

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Makes Recommendations for Reauthorizing Device User Fees

FDA has proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. If adopted, the recommendations would help ensure that safe and effective medical devices get quickly to patients. Under the user fee program, industry covers a portion of the costs of FDA's review process for medical devices.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01609.html

-- Fact sheet: http://www.fda.gov/cdrh/mdufma/mdufmaii-factsheet.html

 

Antibiotic Ointment Approved for Treating Bacterial Skin Infection

FDA has approved Altabax for topical treatment of impetigo, a bacterial skin infection, in patients aged nine months and older. A prescription antibiotic ointment, Altabax should be used only to treat infections proven or strongly suspected of being caused by bacteria.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01607.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

Pet Food Recall:

 

›  FDA is warning consumers that recalled pet food may still be on the shelves in some stores. The agency has conducted about 400 checks of stores around the country, and though the agency says most stores have removed the affected product, it believes some have not.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01605.html 

To see the latest information on the brands of pet food that are being recalled, go to http://www.fda.gov/oc/opacom/hottopics/petfood.html.

 

Drug Recall:

 

›   Grifulvin V (griseofulvin oral suspension), a prescription medicine for treating ringworm and other fungal infections

    Reason for recall: two reports of glass fragments found in the drug bottle; recall is limited to liquid formulation of the drug

http://www.fda.gov/oc/po/firmrecalls/ortho04_07.html

 

Food Recalls:

 

›  Certain olives sold under the brand names Borrelli, Bonta di Puglia, Cento, Corrado's, Dal Raccolto, Flora, Roland, and Vantia with codes that start with the letter "G" and followed by 3 or 4 digits; various sizes

   Reason for recall: possible contamination with Clostridium botulinum bacteria, which can cause potentially deadly botulism

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01608.html

Note: FDA urges consumers not to eat the affected olives. If in doubt, contact the retailer where you bought the product and ask if the olives are part of the recall.

 

›  Various Harry & David candies, 6 oz. size

    Reason for recall: undeclared nuts

http://www.fda.gov/oc/po/firmrecalls/harrydavid204_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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CONGRESSIONAL TESTIMONY

 

April 12 -- FDA Center for Veterinary Medicine Director Stephen F. Sundlof, D.V.M., appeared before the Senate Agriculture, Rural Development, and Related Agencies Appropriations Subcommittee

    Subject: "Contamination of Pet Food"

http://www.fda.gov/ola/2007/petfood041207.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

 

April 24 -- Public meeting to obtain comments about the Animal Drug User Fee Act relative to the program's performance and reauthorization

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-4452.htm

 

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

 

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

 

Where can I get information about clinical trials for cancer or other conditions?

 

Some good sources:

 

»  CancerNet (http://cancernet.nci.nih.gov/) provides links to cancer information, information about ongoing clinical trials, as well as National Cancer Institute fact sheets and other publications.

» Clinical Trials.gov (http://www.clinicaltrials.gov/) can help you locate both government and privately sponsored clinical trials for cancer and other serious illnesses.

»  FDA's Clinical Trials page (http://www.fda.gov/oashi/clinicaltrials/default.htm) provides miscellaneous information for consumers and patients about clinical trials. 

 

 

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