欢迎您注册蒲公英
您需要 登录 才可以下载或查看,没有帐号?立即注册
x
各位大注小注们, 本人在看FDA的指南 ANDA submissions-Content and Format of Abbreviated New Drug Applications,在专利声明这块遇到一个疑难句子。 原句如下:If the RLD is covered by a patent claiming a method of using the listed drug and the labeling for the drug product for which the applicant is seeking approval does not include any indications that are covered by the use patent, the applicant must also submit a statement explaining that the method of use patent does not claim any of the proposed indications (§ 314.94(a)(12)(iii)). 感谢各位交流指点。
|