FDA News Digest for November 10, 2003

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FDA News Digest

November 10, 2003

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FDA Continues Campaign Against Importing of Unapproved Foreign Drugs

FDA is continuing its aggressive campaign to ensure that unapproved and

potentially risky foreign prescription drugs are not imported and sold in

the United States, as evidenced by several recent actions. In one, FDA

informed CanaRx that its business of supplying imported prescription drugs

to the city of Springfield, Mass., is illegal. In another action, FDA

informed Illinois officials that their plans to import foreign drugs will

create potential hazards for patients. And in a related matter, a federal

district judge found that foreign drug importer Rx Depot " violates the law, "

an action that FDA says " sends a clear signal that those who would put

profit before safety will not be allowed to threaten the public health. "

Press release on CanaRx:

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00973.html

FDA letter to Illinois officials:

http://www.fda.gov/oc/opacom/hottopics/importdrugs/kamath.html

FDA statement on Rx Depot decision:

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00974.html

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Congressional Passage of Animal Drug User Fee Act Praised

FDA Commissioner Mark B. McClellan, M.D., has released a statement

commending several members of both houses of Congress for their leadership

in the recent passage of the Animal Drug User Fee Act of 2003. When enacted,

this bill will allow FDA to collect user fees to help speed FDA review of

animal drugs, shortening the time for introduction of new therapies to treat

pets and food-producing animals.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00975.html

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FDA, CDC Set New Rules to Help Prevent Transmission of Monkeypox

New rules, established jointly by FDA and the Centers for Disease Control

and Prevention, aim to prevent transmission of the rare viral disease

monkeypox by restricting the domestic sale and possession of African

rodents, North American prairie dogs, and certain other animals shown to

communicate the disease. Occurring primarily in the rain forests of central

and west Africa, monkeypox was first reported in the United States this

year.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00970.html

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FDA Guidance Stresses Importance of Genetic Differences in Drug Development

FDA has issued guidance that encourages drug and biologic developers to

conduct tests during drug development that take into account small genetic

differences in patients. These differences help explain if a patient will

respond to a drug positively, will not respond at all, or will experience a

side effect. FDA says the promise of this emerging field, known as

pharmacogenomics, is its potential to provide an individualized therapy by

predicting which patients have a greater chance of benefit or risk.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00969.html

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FDA Fines Eye Doctor $1.1 Million for Clinical Study Violations

Louisiana-based ophthalmologist Leon C. LaHaye and the eye care center he

owns have agreed to pay the federal government a total of $1.1 million in

civil penalties for violating federal laws in clinical studies of a laser

system to treat nearsightedness. Violations alleged in the case include use

of an unapproved laser on patients before beginning a study and treating

more subjects than allowed under an FDA-approved study plan.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00972.html

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Seven Universities Awarded Women's Health Research Contracts

FDA's Office of Women's Health has awarded contracts to seven universities

to conduct clinical research on women's health issues. Under one of the

contracts, the University of Arizona will study whether pregnancy changes

the activity of the antidepressant sertraline. Under another contract,

Boston University will examine blood glucose monitoring for diabetes,

comparing fingertip-drawn blood samples with those taken from other

locations on the body.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00971.html

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RECALL

The following product is being recalled for the reason shown. Go to the

linked page for more information.

River Valley Foods Sugar-Free Golden Pound Cake (undeclared milk)

http://www.fda.gov/oc/po/firmrecalls/rivervalley11_03.html

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PUBLIC MEETINGS

Nov. 12 -- FDA Public Workshop on Clinical Trial Endpoints in Colorectal

Cancer; Washington, D.C.

http://www.fda.gov/cder/drug/cancer_endpoints/colonAnnouncement.pdf

Nov. 20 -- FDA Workshop: Exploring the Link Between Food Labeling and Weight

Management; Bethesda, Md.

https://secure.z-techcorp.com/cmt/meetings/meeting_detail.cfm?meeting_id=26

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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