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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
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.
T02-45
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.