Case Study: Proactive Strategies for Meeting NDA Timelines Despite Last-Minute Supplemental Study Requests

Five last-minute studies were accommodated, executed, analyzed, and properly documented for successful NDA submission to the FDA and EMA in just 8 months. Read the full case study here.

Authors:

Sherilyn Adcock, RPh, PhD

Chief Scientific Officer, Early Phase Development

Lona Sheeran

Senior Vice President, Clinical Operations Early Phase