IN THIS WEEK'S
ISSUE
» News
» Recent Speeches
» Upcoming
Public Meetings
»
Question of the
Week
________________________________________________________
'Critical Path' Projects Aim to Advance Product Innovation
As part of its Critical Path initiative, FDA has released a list of 76 high-priority research projects designed to modernize and advance medical product development. The program aims to bring medical innovations to patients faster and at a lower cost. As part of the initiative, FDA and the Critical Path Institute have formed a consortium with five drug companies to share information that will help predict the safety of new treatments before they are tested in humans.
-- Critical Path priority research projects: http://www.fda.gov/bbs/topics/news/2006/NEW01336.html
-- Consortium to predict treatment safety: http://www.fda.gov/bbs/topics/news/2006/NEW01337.html
Imaging System Helps Detect Precursor of Cervical Cancer
FDA has approved the LUMA Cervical Imaging System, a device that can help predict possible cervical cancer development by identifying sites on the cervix that may contain pre-cancerous cells. The device is intended to be used with colposcopy, a high-magnification evaluation for women who have had abnormal findings from Pap screening tests. FDA calls cervical cancer "highly preventable."
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01338.html
FDA Joins Other Agencies to Investigate BSE-Positive Cow
Following announcement of a U.S. Department of Agriculture finding that a cow in the United States tested positive for bovine spongiform encephalopathy (BSE, or "mad cow disease"), FDA has joined state and other federal agencies to investigate the origin of that cow's feed. USDA has confirmed that the cow did not enter the human food or animal feed supply.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01333.html
Advisory Issued Following Possible Link of Mifeprex to Deaths
FDA has recently learned of two deaths following medical abortion with the drug Mifeprex (mifepristone). The agency is investigating the cases but has not yet confirmed a cause of the deaths. Four other deaths possibly linked to use of the drug had been reported since 2003.
http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm
Grand Jury Indicts Florida Man for Selling Fake Cancer Cure
A Florida grand jury has indicted Arthur Vanmoor on numerous charges, including violations of food and drug law, for selling phony cures for cancer and other maladies such as migraines and flu. The indictment alleges that Vanmoor set up Web sites containing "bogus articles from bogus doctors" and that he promoted his products using names of FDA-approved drugs.
http://www.usdoj.gov/usao/fls/060314-01.html
Boyer Named FDA Assistant Commissioner for Legislation
David W. Boyer has been appointed FDA assistant commissioner for legislation. He will oversee the drafting of congressional testimony, respond to congressional inquiries, and assist in the development of public health legislation. Boyer previously held three senior positions in the Department of Health and Human Services, and he has extensive congressional experience. He succeeds Patrick Ronan, now the agency's chief of staff.
http://www.fda.gov/bbs/topics/news/2006/NEW01335.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.
________________________________________________________
Latest FDA Consumer Magazine Available Online
» Inhaled insulin -- A new alternative for 5 million diabetics.
» Migraines -- Treatments include drugs to prevent these headaches and options to stop pain.
» Food labels -- Identifying allergy-triggering ingredients.
» Pain patches -- How to use these products safely.
The issue is
online at http://www.fda.gov/fdac/206_toc.html.
Subscribe to the
print version of FDA Consumer:
http://www.fda.gov/fdac/orderform/fdap.html
RECALLS/SAFETY
ALERTS
Food Recalls:
Entire product lines of H-E-B Baby Food and Mom's Organic Choice
Reason for recall: glass found in the product
http://www.fda.gov/oc/po/firmrecalls/heb03_06.html
Duncan Hines Chocolate Lover's Double Fudge Brownies
Reason for recall: undeclared walnuts
http://www.fda.gov/oc/po/firmrecalls/pinnacle03_06.html
Kroger Cheese Pizza Bites
Reason for recall: undeclared soy
http://www.fda.gov/oc/po/firmrecalls/frozspec03_06.html
Fortune Star White Fungus; 3-oz. size
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/ho03_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.]
_________________________________________________________
RECENT SPEECHES
March 14 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the 13th International Good Manufacturing Practices Conference.
Subject: getting new medical technologies to patients quickly
To view an archive of past speeches by FDA officials, go
to
http://www.fda.gov/speeches/speechli.htm.
UPCOMING PUBLIC MEETINGS
March 22 -- Pediatric Advisory Committee
Under discussion: adverse events reported for attention deficit hyperactivity disorder treatments
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/fda12604d032206amd.html
March 23 -- Psychopharmacologic Drugs Advisory Committee
Under discussion: pending application for a new drug to treat attention deficit hyperactivity disorder
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12544d032306.html
March 27-28 -- Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Under discussion: pending application for a device to prevent post-surgical adhesion
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12524dd03272806.html
April 18-20 -- 2006 FDA Science Forum; includes sessions on drug safety, obesity, avian flu, and non-invasive medical devices. Also planned is a free public session April 18 called "Ask FDA," in which agency scientists will answer questions from consumers about products FDA oversees.
Location:
http://www.fda.gov/scienceforum
For a list of FDA meetings, seminars, and other
public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
_____________________________________________
QUESTION OF THE WEEK
What can I do
to protect myself and my family from food tampering?
Consumers are the final judges of
food safety. An essential step for tampering protection is to check
whether the food container is intact
before opening it. If it has been damaged, dented or opened prior to
purchase, don't use the contents. Be alert also to abnormal odor,
taste and appearance of a food item. If there is any doubt about its safety,
don't eat it. If the food appears to have been tampered with, report it to one
of these authorities:
» If the suspected food product does NOT contain meat or
poultry, consumers should call the FDA 24-hour emergency number at
301-443-1240, or call the consumer complaint coordinator at the nearest FDA
District Office (listed in most phone directories).
» If the food product DOES contain meat or poultry, call
the U.S. Department of Agriculture's Meat and Poultry Hotline at 1-800-535-4555.
For more on food tampering, see http://www.cfsan.fda.gov/~dms/fstamper.html.
_____________________________________________
Thanks for subscribing to FDA News Digest. Our next posting will be March 27.
To
subscribe to or unsubscribe from this list, go to
http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.
___________________________________________________
To learn more about FDA's 100th birthday,
