Recorded November 9, 2022 | On-Demand Webinar
• 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
This session was recorded as part of FDLI’s virtual Introduction to Drug Law and Regulation course in November 2022.