30 January 2018

FDA’s May 2018 eCTD deadline

The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

Important Dates

After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.
• May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.
• May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.