Fixing The FDA's Orange Book

被引：1
|
作者：
Hemphill, C. Scott [1 ]
Sampat, Bhaven N. [2 ]
机构：
[1] NYU, New York, NY USA
[2] Columbia Univ, New York, NY 10027 USA
来源：
HEALTH AFFAIRS | 2022年 / 41卷 / 06期
基金：
欧洲研究理事会; 美国国家科学基金会;
关键词：
PATENTS;
D O I：
10.1377/hlthaff.2022.00369
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch Waxman Act. This regime needs updating. The process that Hatch Waxman established for listing patents and challenging patents on the Food and Drug Administration's Orange Book is one important area for reform.
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页码：797 / 800
页数：4
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