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Abstract
The Modernization Act of 1997 is the result of a partnership between the US Food and
Drug Administration (FDA) and the pharmaceutical industry. Highlights of the Act,
including agreements on user fees, timely review, pediatric studies, and national
registry of clinical trials, are presented. Although progress has been made in each
of these areas, this paper concerns the profound impact of combinatorial chemistry,
genetic research, and pharmacoeconomics on the FDA, the industry, and the drug development
process.
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Copyright
© 1998 Published by Elsevier Inc.
