FDA News Digest for September 4, 2007 (resend due to non-functioning link)

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

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Dear FDA News Digest subscribers,

 

We are resending yesterday's issue because we discovered

a non-functioning link in the item about subscribing to FDA's

monthly consumer health e-newsletter. Because some of you

may be interested in receiving that newsletter, we wanted to

make sure that you have the correct link.

 

We've corrected the link below under the "Consumer Health

Information" section. If you're interested in subscribing to

the consumer health e-newsletter, the correct link is

http://www.fda.gov/consumer/consumerenews.html.

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FDA News Digest

September 4, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Clotting Protein Approved to Help Control Bleeding During Surgery

    -- FDA OKs Second Test for Screening Blood, Organs for West Nile Virus

    -- New Vaccine Licensed to Protect Against Smallpox Infection

    -- Drug Treats Rare Disease Tied to Abnormal Growth Hormone Release

    -- 'FDA Patient Safety News' Video Available Online and as Podcast

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Clotting Protein Approved to Help Control Bleeding During Surgery

FDA has approved Evithrom (human thrombin), a blood-clotting protein that can help control oozing and minor bleeding during surgery. FDA calls the product "an important additional option for surgeons and their patients."

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01690.html

 

FDA OKs Second Test for Screening Blood, Organs for West Nile Virus

FDA has approved the cobas TaqScreen WNV test, the second test approved for screening donated blood and organs for the West Nile virus. The test can detect the genetic material of the virus, indicating whether donated blood or organs have been infected with West Nile even before the donor's body has begun to produce antibodies against the virus.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01691.html

 

New Vaccine Licensed to Protect Against Smallpox Infection

FDA has licensed ACAM2000, a new vaccine that can protect against smallpox, a highly contagious disease that is a potential bioterror weapon. No FDA-approved treatment for smallpox exists, and the only prevention for the disease is vaccination. The new vaccine augments the only other licensed smallpox vaccine, Dryvax, which is in limited supply because it is no longer manufactured.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01693.html

 

Drug Treats Rare Disease Tied to Abnormal Growth Hormone Release

FDA has approved Somatuline Depot (lanreotide acetate injection), to treat acromegaly, a rare and potentially life-threatening disease caused by an abnormal secretion of growth hormone, commonly from a benign tumor in the pituitary gland. Acromegaly affects about 15,000 people in the United States and Canada.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html

 

'FDA Patient Safety News' Video Available Online and as Podcast

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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SAFETY ALERTS/RECALLS

Food Recalls:

 

›  Death by Chocolate cookies, 6-oz. bags with UPC number 19193 00020

   Reason for recall: walnuts may not be declared on package

Press release: http://www.fda.gov/oc/po/firmrecalls/BellaCucina08_07.html

Photo of product: http://www.fda.gov/oc/po/firmrecalls/photos/bellacucina08_07.html

 

›  Marie Callender Turtle Pies, 28-oz. boxes with UPC number 12781 10280

    Reason for recall: a precautionary measure because the product was shipped before obtaining satisfactory microbial test results

http://www.fda.gov/oc/po/firmrecalls/americanpie08_07.html

 

›  Metz Fresh bagged spinach, various sizes with tracking codes 12208114, 12208214 and 12208314

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/metz08_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

Sept. 5 -- FDA Antiviral Drugs Advisory Committee

    Under discussion: pending application for a new drug to treat HIV

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-13560.htm

 

Sept. 10-11 -- Public hearing on using symbols to communicate nutrition information

    Location: Adelphi, Md.

http://www.cfsan.fda.gov/~comm/registe6.html

 

Sept. 11-12 -- Joint meetings of the FDA Cardiovascular and Renal Drugs Advisory Committee and the FDA Drug Safety and Risk Management Advisory Committee

    Under discussion: use of erythropoeisis-stimulating agents when treating anemia due to chronic kidney failure (Sept. 11) and clinical data for a product to reduce blood loss in patients undergoing cardiopulmonary bypass surgery (Sept. 12)

    Location: Gaithersburg, Md.

Sept. 11 -- http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14086.htm

Sept. 12 -- http://www.fda.gov/ohrms/dockets/98fr/e7-14151.htm

 

Sept. 19-20 -- FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a product to reduce adhesion formation in patients undergoing cardiac surgery (Sept. 19) and clinical trial designs for cardiac ablation devices designed to treat patients with medically unresponsive atrial fibrillation (Sept. 20)

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14600.htm

 

Sept. 24-28 -- Parenteral Drug Association/FDA Joint Regulatory Conference (including exhibition and training courses)

    Conference title: "Evolution of the Global Regulatory Environment: A Practical Approach to Change"

    Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/new_conferences_2007pdafda.aspx?articleid=923&zoneid=149 

 

Oct. 1 -- Interagency Working Group on Import Safety

    Under discussion: key challenges/actions for industry, consumers, and governments to ensure the safety of imported products

    Location: Washington, D.C.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-17305.htm

   

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

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

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

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

 

 

CONSUMER HEALTH INFORMATION

 

FDA's Web site features a page with information for consumers. Each week in FDA News Digest, we will spotlight material from that page and offer links to timely articles about FDA activities and products the agency regulates.

 

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

 

› Side Effects of Sleep Drugs

http://www.fda.gov/consumer/features/sleepdrugs073107.html

› Medication Guides for Certain Prescription Products

http://www.fda.gov/consumer/updates/medguides060607.html

› Spot the Block: Get Your Food Facts First

http://www.fda.gov/consumer/updates/spotblock070207.html

 

FDA also has created a free monthly e-newsletter for consumers that contains information posted on the consumer health Web page. To subscribe, go to http://www.fda.gov/consumer/consumerenews.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 September 10.

 

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