Drug Safety: FDA Expedites Many Applications, but Data for Postapproval Oversight Need Improvement

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By Marcia Crosse (au)
Year: 2015
Pages: 47
Binding Paperback
ISBN 978-1-4578-7201-3

Product Code: 1457872013

Description

The Food and Drug Administration (FDA) oversees the safety and effectiveness of drugs sold on the U.S. market. When there is an unmet need for the treatment of a serious condition, FDA may use one or more of its expedited programs, such as fast track and breakthrough therapy designation, which are intended to bring drugs to market more quickly. FDA is also responsible for monitoring the safety of drugs and reporting on those efforts. This report examines (1) the number and types of requests for fast track or breakthrough therapy designation; (2) the number and types of FDA-approved drug applications that used an expedited program; and (3) the extent to which FDAäó»s data on tracked safety issues and postmarket studies allowed the agency to meet its reporting and oversight responsibilities. Table and figures. This is a print on demand report.

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