FDA News Digest for June 4, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

June 4, 2007

__________________________________________

 

IN THIS WEEK'S ISSUE

 

»  News

    -- 7-Day Glucose Monitoring System Approved for Diabetics

    -- New Drug Approved to Treat Advanced Kidney Cancer

    -- Committee Formed to Advise FDA on Risk Communication

    -- Guidelines Finalized for Seasonal/Pandemic Flu Vaccines

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

__________________________________________

 

NEWS

 

7-Day Glucose Monitoring System Approved for Diabetics

FDA has approved the STS-7 System, a device that measures glucose levels continuously for up to seven days in people with diabetes. The device provides extra information to help detect trends and track glucose levels throughout the week -- data that wouldn't be captured by standard fingerstick measurements alone. However, diabetics must still rely on fingerstick tests to decide on how much insulin is needed to treat their disease.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01647.html

 

New Drug Approved to Treat Advanced Kidney Cancer

FDA has approved Torisel (temsirolimus) to treat a certain type of advanced kidney cancer called renal cell carcinoma. Studies have shown an increased survival time for some patients taking the drug. Torisel is the third kidney cancer drug to be approved in the last 18 months. Renal cell carcinoma is diagnosed in about 51,000 people yearly in the United States.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01644.html

 

Committee Formed to Advise FDA on Risk Communication

FDA has announced the formation of a new advisory committee that will advise the agency on how to communicate to the public the risks and benefits of FDA-regulated products. The agency calls such communication essential to helping consumers and health professionals make informed decisions. The committee will have 15 voting members, including experts and public members not affiliated with FDA.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01648.html

 

Guidelines Finalized for Seasonal/Pandemic Flu Vaccines

FDA has issued final guidelines for industry to help increase the supply of flu vaccines for seasonal and pandemic use. The agency created the guidelines to outline the regulatory process for rapid development and approval of these vaccines.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01645.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.]

___________________________________________

 

RECALLS/SAFETY ALERTS

Pet Food Recall/Tainted Animal Feed:

 

›  FDA has a special page that lists the latest information on recalled pet foods and tainted animal feed: 

http://www.fda.gov/oc/opacom/hottopics/petfood.html

 

Food Recalls:

 

›   King Chief brand Dried Lily Flowers, 6 oz. size

    Reason for recall: sulfites in product not listed

http://www.fda.gov/oc/po/firmrecalls/domega05_07.html

›   Lucky Eight brand Dried Lily Bulb, 12 oz. size

    Reason for recall: sulfites in product not listed

http://www.fda.gov/oc/po/firmrecalls/murray05_07.html

  

Safety Alert:

 

FDA is warning consumers to avoid using tubes of toothpaste with labels indicating the product is made in China. The agency is concerned that these products may contain diethylene glycol, a poisonous chemical used in antifreeze and as a solvent.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01646.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.]

_____________________________________________

 

UPCOMING PUBLIC MEETINGS

June 11-12 -- 10th Annual FDA-Orange County Regulatory Affairs Educational Conference

    Location: Irvine, Calif.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6052.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

 

June 13 -- Endocrinologic and Metabolic Drugs Advisory Committee

    Under discussion: pending application for a drug treatment for obesity

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-5506.htm

 

June 27 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

    Under discussion: oncology products granted pediatric exclusivity under the Best Pharmaceuticals for Children Act

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-8656.htm

 

June 27 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats atrial flutter

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-9054.htm

 

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

 

What is arthritis, and why do people get it?

Arthritis is a disease of the joints. Painful, stiff joints are the most common signs of arthritis. Other signs are swelling, warmth, and redness in the joints. People with arthritis often have trouble moving the joints normally.

 

Arthritis is a problem for many adults 65 and older. About 42 million Americans have some form of arthritis. It can affect people of all ages and races.

 

People get arthritis because:

-- They put stress on joints over time.

-- They are overweight.

-- It runs in their family.

-- They are women. Women are affected two to three times more often than men.

 

For more on arthritis, see http://www.fda.gov/womens/getthefacts/arthritis.html.

 

 

Thanks for subscribing to FDA News Digest.

Our next issue will be sent June 11.

 

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

 

To subscribe to or unsubscribe from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.