PDA Letter Article

Are You Ready for the eCTD Mandate?

by Mckenzie Orchowski, Biologics Consulting

Computer Book

Regulatory submissions to the U.S. FDA for NDAs, BLAs, and ANDAs must be submitted in electronic Common Technical Document (eCTD) format. This requirement has been in place since May 5, 2017, per the timeline set forth in the “umbrella” guidance (1).