Updated FDA Guidance - Providing Regulatory Submissions in Electronic Format

FDA publishes update to the guidance, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications that provides for a one-year extension of the deadline for Drug Master Files (DMFs) to be submitted in electronic format.  The new deadline is May 5, 2018 and replaces the earlier deadline of May 5, 2017.

Access guidance here.