Good News!! FDA Extends deadline for eCTD DMF Submission to May 5, 2018!!
As per the requirements under the FD&C Act, FDA issued guidance on May 5, 2015 “Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” which established a mandatory requirement for eCTD submission for NDA, BLA, IND, ANDA, and DMF. Submissions that are not