FDA News
Digest
March 14, 2005
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IN THIS WEEK'S ISSUE
-- Potential Cancer Risk Prompts FDA Advisory on 2 Eczema Drugs
-- FDA Offers Patient Information on Recently Approved Devices
-- FDA Web Site Receives 'Silver' Award in Health Information Contest
-- Latest FDA Consumer Magazine Available Online
-- Recalls/Market Withdrawals
-- Public Meetings
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Potential Cancer Risk Prompts FDA Advisory on 2 Eczema Drugs
Following findings of a potential cancer risk associated with the eczema treatments Elidel and Protopic, FDA is advising healthcare professionals to prescribe the drugs only as directed and only after other eczema treatments have failed. The agency also is adding a "black box" warning to the labeling of both drugs and is developing a medication guide for patients.
-- Press release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01343.html
-- Public health advisory: http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm
FDA Offers Patient Information on Recently Approved Devices
FDA's Center for Devices and Radiological Health has published consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices, explains what they are intended to do, and tells how they should and should not be used.
-- Advia Centaur HCV Assay (for diagnosing hepatitis C virus): http://www.fda.gov/cdrh/mda/docs/p030056.html
-- Reflection Ceramic Acetabular System (an artificial hip replacement system): http://www.fda.gov/cdrh/mda/docs/p030022.html
-- InSite Her-2/neu kit (identifies breast cancer patients eligible for treatment with the drug Herceptin): http://www.fda.gov/cdrh/mda/docs/p040030.html
FDA Web Site Receives 'Silver' Award in Health Information Contest
FDA's Web site (www.fda.gov) has received a "Silver" award in the Fall/Winter 2004 World Wide Web Health Awards competition. The semiannual contest is sponsored by the Health Information Resources Center (HIRC), a clearinghouse for consumer health information. The awards act as a "seal of approval" for health-related Web sites aimed at consumers and health professionals, HIRC says.
http://www.fda.gov/bbs/topics/news/2005/NEW01164.html
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Latest FDA Consumer Magazine Available Online
The March-April 2005 issue of FDA Consumer has articles on the following topics:
-- Stroke -- The latest information on the third-leading cause of death for Americans.
-- Arthritis -- Advice on managing the crippling pain and inflammation of this disorder.
-- "PillCam" -- This new tool takes snapshots of the digestive system.
-- Teen tanning -- FDA discourages the use of tanning devices.
-- Radiofrequency identification -- Electronic tags can track drugs through the distribution process.
-- Dietary guidelines -- The latest federal advice stresses calorie control and exercise.
-- FDA Science Forum -- A free consumer session in Washington, D.C., April 26 will discuss personalizing your healthcare.
The issue is online at http://www.fda.gov/fdac/205_toc.html.
Subscribe to FDA Consumer:
http://www.fda.gov/fdac/orderform/fdap.html.
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RECALLS/MARKET
WITHDRAWALS
The following
products are being recalled for the reasons shown. Go to the linked page for
more information.
For a list of
recalls, market withdrawals, and safety alerts involving FDA-regulated products
from the last 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
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RECENT SPEECHES
FDA Acting Commissioner Lester M. Crawford, D.V.M., before the U.S. Pharmacopeia Convention (March 11)
http://www.fda.gov/oc/speeches/2005/pharmacopeia311.html
To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm
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PUBLIC
MEETINGS
March 15 -- FDA Vaccines and Related Biological Products Advisory Committee; under discussion: safety and immunogenicity of two tetanus diphtheria and pertussis vaccines (Bethesda, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cber12391d031505.html
March 17-18 -- FDA Blood Products Advisory Committee; under discussion: transmissible spongiform encephalopathies, West Nile virus, and FDA's Critical Path Initiative (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516dd03171805.html
March 21-22 -- FDA/New Mexico University Food Labeling Public Workshop; intended to provide information about FDA food labeling regulations and other related subjects to regulated industry, especially small businesses and startups (Las Cruces, N.M.)
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2450.htm
March 21 -- Public hearing on reporting adverse events to institutional review boards (Rockville, Md.)
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2300.htm
March 23 -- FDA Nonprescription Drugs Advisory Committee; under discussion: processes used to demonstrate the effectiveness of antiseptic products in health care settings (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12541d032305.html
March 24 -- Joint meeting of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; under discussion: evaluating the switch of topical corticosteroids from prescription to over-the-counter status (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12534d032405.html
April 5-6 -- Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; a forum for comments on a safety program designed to minimize public health hazards posed by animal feed products (Omaha, Neb.)
http://www.fda.gov/cvm/index/animalfeed/AFSSMtg/AFSSMtg042005.htm
April 5-6 -- FDA/University of Arkansas workshop on food labeling; intended to provide information about FDA food labeling regulations and related subjects to regulated industry, especially small businesses and startups (Fayetteville, Ark.)
For a list of FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html
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