Fed Regist. 1997 Nov 28;62(229):63268-9.
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is publishing this document to clarify the status of its practices governing 180 days of marketing exclusivity for generic drugs and the approval of abbreviated new drug applications (ANDA's) subject to patent litigation. This document is being published due to recent court decisions interpreting provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments).
美国食品药品监督管理局（FDA）药品评价和研究中心（CDER）发布本文件，以澄清其关于仿制药180天市场独占期的管理做法以及涉及专利诉讼的简略新药申请（ANDA）的批准情况。发布本文件是由于近期法院对1984年《药品价格竞争和专利期限恢复法案》（公法98 - 417）（1984年修正案）条款的解释性判决。
