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i (2005)

handle is hein.cbhear/cbhearings92633 and id is 1 raw text is: FDA'S DRUG S. HRG. 109-67 APPROVAL PROCESS: UP TO THE CHALLENGE? HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED NINTH CONGRESS FIRST SESSION ON EXAMINING FOOD AND DRUG ADMINISTRATION'S (FDA) DRUG AP- PROVAL PROCESS, FOCUSING ON FDA'S DRUG APPROVAL PROCESS AFTER A SPONSOR DEMONSTRATES THAT THEIR BENEFITS OUT- WEIGH THEIR RISKS FOR A SPECIFIC POPULATION AND USE, AND THAT THE DRUG MEET MEETS STANDARDS FOR SAFETY AND EFFI- CACY MARCH 1, 2005 Printed for the use of the Committee on Health, Education, Labor, and Pensions U.S. GOVERNMENT PRINTING OFFICE 99-761 PDF WASHINGTON : 2005 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001

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