FDA News Digest for January 20, 2004

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FDA News Digest
January 20, 2004
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FDA Sees Improvements in Approval of Innovative Drugs in 2003

FDA reports that in 2003 the agency made improvements over the previous year
in approvals of drugs and biologics. This included decreases in the time
taken to review and approve most applications. As part of this performance,
FDA approved 21 products with active ingredients never before marketed in
the United States.
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html
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FDA Advances Consumer Health and Safety in 2003

FDA has released a report highlighting some of the agency's priorities and
initiatives to protect consumer health and safety in 2003. The report
describes how FDA plans to build on these initiatives in 2004. Highlighted
agency programs include those that combat new forms of terrorism and
emerging diseases, crack down on false products and claims, and reduce
preventable medical errors.
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01004.html
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FDA Deputy Commissioner Joins BSE Delegation to Japan and Korea

FDA Deputy Commissioner Lester M. Crawford, D.V.M., is a member of a U.S.
government delegation to Japan and Korea to discuss bovine spongiform
encephalopathy (BSE or mad cow disease) with officials from the two Asian
countries. The group, which departed Jan. 20, will discuss all aspects of
the first confirmed case of BSE in the United States, reported on Dec. 23.
Crawford is the delegation's expert on FDA-related aspects of BSE,
especially the "animal feed" rule, designed to help prevent the spread of
BSE in the United States.
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01006.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.

Lactalis USA President Brie Soft-ripened Cheese Double Cream in Green Foil
(herb) and Gold Foil (plain); expanded recall (possible contamination with
Listeria monocytogenes)
http://www.fda.gov/oc/po/firmrecalls/lactalis01_04.html

7-Eleven "Big Eats" Stacked Ham/Turkey Club on Buttermilk Bread (possible
contamination with Listeria monocytogenes)
http://www.fda.gov/oc/po/firmrecalls/7Eleven01_04.html
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Latest FDA Consumer Magazine Available Online
The January-February 2004 issue of FDA Consumer has articles on the
following topics:

*       Fighting terrorism -- FDA's commissioner has made counterterrorism a
top priority.
*       Preventing Listeria contamination -- Follow these tips when handling
or preparing food.
*       Obesity -- The food industry, consumer groups and others are helping
FDA tackle this public health problem.
*       Keeping pets (and people) healthy -- Some easy-to-follow steps.
*       Cervical cancer -- Regular screening tests can help women prevent
this disease.
*       Ultrasound "keepsakes" -- FDA discourages expectant mothers from
receiving casual images from this technology.
*       Advisory committees -- These forums help FDA make regulatory
decisions.
*       Older Hispanic Americans -- FDA has teamed up with the
Administration on Aging to help prevent diseases in Hispanic American
seniors.

Also included is an editorial on the importance of animals and animal
health.

The issue is online at http://www.fda.gov/fdac/104_toc.html.
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PUBLIC MEETINGS

For a list of upcoming FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html.
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