FDA News Digest for November 13, 2007

FDA News Digest <fdanewsdigest@xxxxxxxxxx> · Tue, 13 Nov 2007 16:40:35 -0500

FDA News Digest
November 13, 2007
______________________________________

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__________________________________________

IN 
THIS WEEK'S ISSUE

»  
News
    --  Plan Unveiled to Boost, Update Food Safety 
Efforts 

    --  FDA 
Strengthens Warnings for Three Anemia 
Drugs 

--  Prescription Allergy Drug Zyrtec-D Now Available 
OTC 

    --  Silver-Coated Breathing Tube Reduces Pneumonia 
Risk 

    --  'FDA Patient Safety News' Video, Podcast 
Available 

»  Congressional 
Testimony 
»  Safety 
Alerts/Recalls 

»  Upcoming 
Public Meetings 
»  Consumer Health Information 

__________________________________________ 

NEWS

Plan Unveiled to Boost, Update Food Safety 
Efforts
FDA has launched a program designed to bolster efforts 
to protect the nation's food supply. Called the Food Protection Plan, the 
program proposes using science and a risk-based approach to ensure the safety of 
domestic and imported 
foods.
›  Press release: 
http://www.hhs.gov/news/press/2007pres/11/pr20071106a.html
›  Food 
Protection Plan: http://www.fda.gov/oc/initiatives/advance/food/plan.html

FDA Strengthens Warnings for Three Anemia 
Drugs
FDA 
has approved revised boxed warnings and other safety-related labeling changes 
for erythropoiesis-stimulating agents, which are used to treat certain types of 
anemia. The new statements address the risks that the drugs Aranesp, Epogen, and 
Procrit pose to patients with cancer or with chronic kidney 
failure.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html

Prescription Allergy Drug 
Zyrtec-D Now Available OTC
FDA has approved the allergy drug Zyrtec-D, previously 
available only by prescription, for nonprescription use in adults and children 
aged 12 and older. Hay fever and other allergies are the sixth leading cause of 
chronic disease, affecting about 50 million yearly in the United States, 
according to government figures.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01742.html

Silver-Coated Breathing 
Tube Reduces Pneumonia Risk
FDA has cleared for marketing the silver-coated Agento 
endotracheal tube, which reduces the risk that patients on ventilators will get 
pneumonia while in the hospital. Patients requiring breathing support are at 
risk of exposure to hospital-acquired bacteria that can build up on the 
breathing tube. Because silver is known to have antimicrobial properties, it can 
help lower pneumonia risk.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01741.html

'FDA Patient Safety News' 
Video , Podcast 
Available

FDA has posted the latest 
edition of "FDA 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. 

-- To view video or 
text version: http://www.fda.gov/psn
-- To access Podcast: 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.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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CONGRESSIONAL 
TESTIMONY

Nov. 13 -- FDA Assistant Commissioner for 
Food Protection David Acheson, M.D., appeared before the 
House Subcommittee on Oversight and 
Investigations.
    Subject: FDA's new Food 
Protection Plan

http://www.fda.gov/ola/2007/foodsafety111307.html 

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

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

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SAFETY 
ALERTS/RECALLS 

Tableware 
Recall:

›  Romano Pitchers and 
Tumblers
Reason for recall: may contain high lead 
levels
http://www.fda.gov/oc/po/firmrecalls/napastyle11_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 

Nov. 27-29 -- 
Pediatric Advisory Committee
    Under 
discussion: adverse event reports related to the drug Tamiflu (Nov. 27-28); 
labeling of drugs for lactating women (Nov. 
29)

Location: Gaithersburg, Md.
›  
Nov. 
27-28: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20302.htm
›  Nov. 29: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20304.htm

For 
a complete list of FDA meetings, 
seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH 
INFORMATION

Each week in FDA News Digest, we will 
spotlight consumer 
health information by offering 
links to timely articles about FDA activities and products the agency 
regulates.

Here's what's in the spotlight this 
week:

›  Focusing on Contact Lens 
Safety

http://www.fda.gov/consumer/features/contactlens1107.html

›  
Getting Up to Date on 
Glucose Meters
http://www.fda.gov/consumer/updates/glucosemeters110107.html

For those who are members of the press or who manage 
Web sites, we encourage you to link to this information or incorporate it into 
your online or printed publications. (We'd appreciate a credit to "FDA Consumer 
Health Information.")
Questions or comments 
about our consumer stories or the consumer health e-newsletter? Send 
an e-mail to fdaconsumerlist@xxxxxxxxxx.  

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Our next issue will be sent November 19. 

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