Wolgemuth R L
Glaxo Wellcome Inc., Research Triangle Park, North Carolina 27709, USA.
Clin Ther. 1998;20 Suppl C:C26-31. doi: 10.1016/s0149-2918(98)80005-2.
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.
1997年的《现代化法案》是美国食品药品监督管理局（FDA）与制药行业合作的成果。文中介绍了该法案的要点，包括用户费用协议、及时审评、儿科研究以及临床试验国家登记等方面。尽管在上述各个领域都取得了进展，但本文关注的是组合化学、基因研究和药物经济学对FDA、制药行业以及药物研发过程产生的深远影响。
