FDA News Digest for August 27, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

August 27, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  FDA Proposal Sets New Standards for Sunscreen Products

    --  Drug OK'd for Two Psychiatric Conditions in Children, Adolescents

»  Safety Alerts/Recalls

»  Upcoming Meetings

»  Consumer Health Information NEW FEATURE!

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NEWS

 

FDA Proposal Sets New Standards for Sunscreen Products

FDA has proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter sunscreen products with ultraviolet A (UVA) and ultraviolet B (UVB) protection. UVA light is responsible for tanning and UVB for sunburn; both can damage skin and increase skin cancer risk. The FDA proposal creates a star system to rate a product's degree of protection from UVA rays.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01687.html

 

Drug OK'd for Two Psychiatric Conditions in Children, Adolescents

FDA has approved Risperdal (risperidone) to treat schizophrenia in adolescents (ages 13 to 17) and for short-term treatment of manic or mixed episodes of bipolar 1 disorder in children and adolescents (ages 10 to 17).

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01686.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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SAFETY ALERTS/RECALLS

Safety Alert:

 

›  FDA is expanding its earlier warning to avoid eating raw oysters from the southern tip of Hood Canal in Washington state to include an additional growing area of the canal. The warning follows a foodborne illness outbreak caused by a form of Vibrio bacteria.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01688.html

 

Food Recall:

 

›  Genuine Sweet Baby Carrots sold under the labels Los Angeles Salad and Trader Joe's

    Reason for recall: possible Shigella bacteria contamination

http://www.fda.gov/oc/po/firmrecalls/lasalad08_07.html

 

Pet Food Recall:

 

›  Krasdale Gravy dry dog food (5-lb. bags) and Red Flannel Large Breed Adult Formula dry dog food (50-lb. bags)

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01689.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 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 

   

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 has created a Web page with information for consumers. Each week in this space, we will spotlight material from that page and offer links to timely articles about FDA activities and products the agency regulates.

 

Here's a sampling of consumer health stories:

 

› A Parent’s Guide to Kids’ Vaccines -- http://www.fda.gov/consumer/updates/kidsvaccines073107.html

› FDA Law Enforcers Protect Consumers’ Health -- http://www.fda.gov/consumer/updates/oci072307.html

› Recognizing Recalled Foods -- http://www.fda.gov/consumer/updates/recalledfoods061307.html

› FDA Readies for More Nanoscale Challenges -- http://www.fda.gov/consumer/updates/nanotech072507.html  

 

FDA also has created a free monthly e-newsletter for consumers that contains information posted on the consumer 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 and printed publications to give your readers quick access to easy-to-understand information. (We'd appreciate a credit to "FDA Consumer Health Information.")

 

We hope you like our new feature. If you have any questions or comments about our consumer health stories or the e-newsletter, send an e-mail to fdaconsumerlist@xxxxxxxxxx.   

  

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Our next issue will be sent September 4.

 

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