法律是基于FDA和仿制药行业代表的谈判协议的，其中讨论了日益增加的法规挑战。
The law is based on an agreement negotiated by FDA andrepresentatives of the generic drug industry to address a growing number of regulatorychallenges.
如果他们只是生产仿制药，那只是在复制，不是一个真正的制药行业。
If they're just doing generic drugs, just copies, that's not a real pharmaceutical industry.
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