FW: FDA News Digest for May 5, 2003

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FDA News Digest for May 5, 2003

FDA News Digest

May 5, 2003

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New Drug Treats Most Common Type of Lung Cancer

FDA has approved Iressa (gefitinib) tablets for treatment of advanced

non-small cell lung cancer, the most common form of lung cancer in the

United States. Iressa is intended for patients whose cancer has

progressed despite treatment with other chemotherapy drugs. FDA approved

Iressa under a program that allows accelerated approvals of therapies

for patients with serious diseases. Press release:

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00901.html

Iressa information page:

http://www.fda.gov/cder/drug/infopage/iressa/default.htm

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New Test Monitors Asthma by Measuring Nitric Oxide in Breath

FDA has cleared for marketing a first-of-a-kind test that should help

doctors monitor a patient's response to anti-inflammatory asthma

treatment by measuring the concentration of nitric oxide in the

patient's breath. A decrease in exhaled nitric oxide suggests that

treatment may be reducing the lung inflammation associated with asthma.

The disease affects about 15 million Americans.

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01219.html

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First Product Approved for Treating Rare Enzyme Deficiency

FDA has approved Aldurazyme, the first treatment for patients with

certain forms of a rare genetic disease called MPS1, which includes

Hurler Syndrome. The disease results from the absence or malfunctioning

of an enzyme that breaks down certain molecules in the cells. The

buildup of these molecules results in cellular damage that affects

appearance, physical abilities, organ functions and, in some cases,

mental development.

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01218.html

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FDA, Tech Firm Join Forces to Evaluate Adverse Event Data

FDA has signed an agreement with Lincoln Technologies Inc., to use " data

mining " techniques to evaluate data that FDA collects about adverse

events involving approved drugs, biological products and vaccines.

Through the partnership, FDA aims to identify patterns of adverse

events, allowing the agency to take quick action to prevent future

occurrences. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00899.html

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FDA, Hispanic Health Group Announce Improved Information Access

FDA has joined with the National Alliance for Hispanic Health to help

improve access to health information for Hispanic communities across the

United States. Program goals include delivering information through a

new toll-free help line and enhancing dialogue between the agency and

Hispanic leaders on key health issues. Press release (Spanish):

http://www.fda.gov/bbs/topics/NEWS/spanish/span00900.html

Press release (English):

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00900.html

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False Health Claims Prompt Destruction of 'Nature's Youth' Supplements

Massachusetts-based Nature's Youth LLC, has voluntarily destroyed

$515,000 worth of its Nature's Youth hGH after FDA determined the

company made false and misleading claims about the product on its

website and in labeling. These claims included an unsubstantiated

statement that Nature's Youth hGH enhances " the body's natural

production of Human Growth Factors and Insulin-like Growth Factor-1. "

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00898.html

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RECALLS

The following products have been recalled for the reasons shown. Go to

the linked page for more information:

White Wave Vanilla Silk Soymilk (contaminant)

http://www.fda.gov/oc/po/firmrecalls/whitewave2_04_03.html

Peregrina Cheese Corp. Queso Fresco, Fresh Cheese (Listeria

contamination)

http://www.fda.gov/oc/po/firmrecalls/peregrina_state04_03.html

Cosmeceutical Creations Corp. Dee Ann Jet Black Mascara

(bacterial

contamination)

http://www.fda.gov/oc/po/firmrecalls/cosmeceutical04_03.html

Forever Cheese Inc. Mitica Apricot Bars (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/forevercheese04_03.html

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PUBLIC MEETINGS

May 7 Public Meeting, Satellite Broadcast to Discuss Bioterrorism Act

FDA will sponsor a public meeting May 7 to discuss two sections of the

Bioterrorism Act of 2002 regarding establishment and maintenance of

records for foods and administrative detention of foods. The meeting

will be broadcast by satellite to locations across the country,

including sites in California, Florida, Massachusetts, and Ohio.

http://www.fda.gov/CDRH/OHIP/DCM/html/cfsan_bio_2_event_page.html

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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