FDA News Digest
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IN THIS WEEK'S ISSUE
» 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 Approves First Inhalable Insulin to Treat Diabetes
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
http://www.fda.gov/bbs/topics/news/2006/NEW01304.html
New Drug Approved to Treat Two Types
of Cancer
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.
http://www.fda.gov/bbs/topics/news/2006/NEW01302.htmlin
Contamination Prompts FDA to Seek
Shutdown of Fish Facility
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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RECALLS/SAFETY
ALERTS
Device Recall:
Vapotherm 2000i and 2000h
respiratory gas humidifier
Reason for recall:
possible bacterial contamination
http://www.fda.gov/cdrh/recalls/recall-101305.html
Food
Recalls:
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
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
Location:
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:
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:
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:
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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QUESTION OF THE WEEK
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
For more on whole-body CT scanning,
see http://www.fda.gov/cdrh/ct/.
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