- Recognize the content and organization of a full New Drug Application
- Become familiar with:
- User fees and goals under the Prescription Drug User Fee Act (PDUFA)
- Expedited review programs
- Best practices when interacting with FDA
Charles G. Raver, Associate, Hyman, Phelps, & McNamara, PC
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2022.