US FDA Provides Reminders For Upcoming eCTD Validation Changes

By Cary Smithson

As always, the Ask the Regulators Sessions were well-attended and full of practical questions and thoughtful responses. The presentation by US FDA’s Jonathan Resnick, Project Management Officer from the Office of Business Informatics, Center for Drug Evaluation and Research, offered great practical reminders of imminent changes that will impact submissions starting next month.  

In his Electronic Submissions Update, Resnick reminded the audience about two significant short-term changes that will become effective March 1, 2022.