Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Evan Richardson2025 年 2 月 3 日
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…
Evan Richardson2016 年 3 月 14 日
