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" News

-- FDA Approves First Inhalable Insulin to Treat Diabetes

-- New Drug Approved to Treat Two Types of Cancer

-- Contamination Prompts FDA to Seek Shutdown of Fish Facility

" Recalls/Safety Alerts

" Upcoming Public Meetings

" Question of the Week

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FDA has approved Exubera, the first inhaled form of insulin. Exubera offers a potential alternative for the more than 5 million Type 1 and Type 2 diabetics in the United States who take insulin injections. Many diabetics require insulin treatment to control levels of sugar in the blood, which helps ward off serious complications such as heart disease, kidney failure, blindness, and nerve damage. Exubera is the first new delivery option approved since insulin was discovered in the 1920s.

http://www.fda.gov/bbs/topics/news/2006/NEW01304.html

FDA has approved Sutent, an anti-cancer treatment for patients with gastrointestinal stromal tumors (GIST) or with advanced kidney cancer. The action marks the first time the agency has approved a drug initially to treat two types of disease. Sutent is a "targeted" therapy that works by depriving cancer cells of the blood and nutrients they need to grow. The American Cancer Society says 5,000 cases of GIST and 32,000 cases of advanced kidney cancer are diagnosed yearly.

Following recent FDA inspections that revealed disease-causing Listeria monocytogenes contamination at California-based Pacific Shellfish's facility and in the company's fish products, the agency is seeking a court order to shut the company down until it corrects the contamination problems, which are considered violations under food and drug law. The company promised corrections after a 2004 inspection, but a follow-up inspection in 2005 revealed continuing contamination problems.

http://www.fda.gov/bbs/topics/news/2006/NEW01303.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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Vapotherm 2000i and 2000h respiratory gas humidifier

Reason for recall: possible bacterial contamination

http://www.fda.gov/cdrh/recalls/recall-101305.html

Certain lots of Aunt Jemima Cinnamon French Toast and Aunt Jemima Home Style Low-Fat Waffles

Reason for recall: undeclared egg

http://www.fda.gov/oc/po/firmrecalls/pinnacle01_06.html

Certain lots of juices with the brand name Evolution, Harvest, or Trader Joe's; various sizes

Reason for recall: possible bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/juiceharvest01_06.html

Swad brand Dry Dates; 7-oz. size

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/rajah01_06.html

Various chicken salad, egg salad, ham salad, and tuna salad sandwiches distributed in Illinois and Iowa by Hasty Tasty Food Service Inc.

Reason for recall: undeclared dairy products

http://www.fda.gov/oc/po/firmrecalls/hastytasty01_06.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

Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative Public Workshop and Vendor Display

Under discussion: adoption of radio-frequency identification in the U.S. medicine supply chain to combat counterfeit products

Location: Bethesda, Md.

http://www.fda.gov/rfidmeeting.html

Feb. 8-9 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

Under discussion: industry and FDA perspectives on proper conduct of FDA-regulated clinical trials

Location: Houston, Texas

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18871.htm

Feb. 9-10 -- Cellular, Tissue and Gene Therapies Advisory Committee

Under discussion: the National Toxicology Program on Retroviral Mutagenesis

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cber12389dd02091006.html

Feb. 9-10 -- Drug Safety and Risk Management Advisory Committee

Under discussion: potential serious adverse effects of drugs to treat attention deficit hyperactivity disorder

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12535dd02091006.html

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

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

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What are whole-body CT scans, and do they have value as a screening tool for healthy patients?

Currently some medical imaging facilities are promoting an alternate use of computed tomography (CT), also called computerized axial tomography (CAT) scanning. This use sometimes is referred to as whole-body CT scanning or whole-body CT screening, marketed as a preventive or proactive healthcare measure to healthy individuals who have no symptoms or suspicion of disease.

At this time FDA knows of no data demonstrating that whole-body CT screening is effective in detecting any particular disease early enough for the disease to be managed, treated, or cured and advantageously spare a person at least some of the detriment associated with serious illness or premature death. Any such presumed benefit of whole-body CT screening is currently uncertain, and such benefit may not be great enough to offset the potential harm such screening could cause.

Public health agencies and many national medical and professional societies -- including the American College of Radiology, the American Association of Physicists in Medicine, the Health Physics Society, and the American Medical Association -- do not recommend CT screening.

For more on whole-body CT scanning, see http://www.fda.gov/cdrh/ct/.

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