《Referencing approved drug products in ANDA submissions》
A 505b1 application, also known as a "stand-alone" DNA, is an application that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use.
1. stand-alone NDA是指独立新药申请还是卓越新药申请?
2. 药物全面的安全性和有效性研究conducted by申请人我可以理解,conducted for the applicant怎么理解?
3. 最后是不是翻译为:这个全面的investigation也可被仿制药申请人有权利地引用?