FDA has published final guidance that mandates a May 2017 deadline for all NDAs/BLAs/ANDAs/DMFs to be submitted in eCTD format. Exemptions from the mandate and deadline will not be granted commercial sponsors. In the meantime, the only electronic submission format accepted by FDA is eCTD and FDA is requiring eCTD in special cases ahead of the deadline.
Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.