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M E M O R A N D U M
To: Reporters and Editors
Fr: Jill Gerber, 202/224-6522
Re: Welfare, Medicaid, and S-CHIP
Da: Thursday, Nov. 7, 2002
Sen. Chuck Grassley, ranking member of the Committee on Finance, today made the following comment on his intentions for welfare, Medicaid, and the State Children's Health Insurance Program when he resumes the committee chairmanship.
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Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly significant provisions:
* User fees for premarket reviews.
* Establishment inspections may be conducted by accredited persons (third-parties),
FOR IMMEDIATE RELEASE
P02-49
November 7, 2002
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA APPROVES NEW RAPID HIV TEST KIT
HHS Secretary Tommy G. Thompson today announced that the U.S. Food and Drug Administration has approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes.
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