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FOR IMMEDIATE RELEASE

November 20, 2002

AMA: SENATE FAILS MEDICARE PATIENTS

Congress has narrow window of opportunity in January to avert Medicare crisis

The U.S. Senate has chosen to leave Washington without fixing the Medicare physician payment mistake that is threatening access to care for America's seniors.


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DRUG COMPETITION ACT OF 2001 -- (Senate - November 18, 2002)
[Page: S11339]    The PRESIDING OFFICER. The clerk will report the bill by title.    [Strike the part shown in black brackets and insert the part shown in Italic.]     Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, [SECTION 1. SHORT TITLE.    [SEC. 2. FINDINGS.

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BIO STATEMENT ON PRODIGENE, INC.

For Immediate Release

11/15/02

Contact:

Lisa Dry

Direct (202) 962-9231

Cell (202) 345-3673

WASHINGTON, D.C. (November 15, 2002) - Biotechnology Industry Organization (BIO) Executive Director for Food and Agriculture Michael J. Phillips today issued the following statement regarding regulatory infractions by ProdiGene, Inc. as announced by the Animal Plant Health and Inspection Service of the U.S. Department of Agriculture:


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After an extensive external and internal search, it is with great pleasure we announce that Dr. Mary Purucker has accepted the offer to become CDER's first Division Director for Counter-Terrorism. Dr. Purucker will begin her new position December 2, 2002. She brings to the position excellent scientific and clinical training, extensive regulatory experience and a strong commitment to public health and the Commissioned Corps.


CONFERENCE ANNOUNCEMENT

Contact: Diane Dorman

Examining the Roadmap to Therapeutically

Equivalent Biologics

Danbury, Connecticut, November 18, 2002 -- The National Organization for Rare Disorders (NORD) announced today it will hold a one-day conference in March 2003 to explore the scientific, economic, and regulatory feasibility of developing and marketing therapeutically equivalent biologics. There is currently no regulatory pathway at the U.S. Food and Drug Administration for doing this after patents expire.


CDC released its latest update on the recent outbreak of Listeriosis in the northeastern United States. The outbreak, effecting 52 people to date, has been linked to ready-to-eat poultry products produced by Pilgrim's Pride Corporation and Jack Lambersky Poultry Company. Click here for the CDC Release


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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

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Media Inquiries: 301-827-6242

November 18, 2002

Consumer Inquiries: 888-INFO-FDA

FDA CLEARS NEW LAB TEST FOR GROUP B STREP IN PREGNANT WOMEN

The Food and Drug Administration today cleared for marketing a new laboratory test for Group B Streptococcus in pregnant women.


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FOR IMMEDIATE RELEASE

Contact: Judy Blatman at 202-263-1005

WASHINGTON, D.C., November 19, 2002 - The Council for Responsible Nutrition (CRN), one of the dietary supplement industry's leading trade associations, today commended the American Heart Association (AHA) for urging people to consume omega-3 fatty acids to protect their hearts.


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