FDA Delays eCTD Requirements for DMF and BPF by 1 year

Yesterday (Friday April 7, 2017) the FDA announced in an updated guidance that it has delayed until May 5, 2018 the requirement for DMF and BPF submissions to be submitted in eCTD format. Other submission types, NDA, ANDA and BLA, must still meet the 5 May 2017 deadline for submission in eCTD format. For those who have already converted their DMF submissions to eCTD format, you are now 1 year ahead!


Revised FDA Guidance:

4/7/2017 Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (ucm333969.pdf)

RAPS article: