On April 7th 2017, the FDA announced, in response to industry comments and internal review, that is postponing by one year the compliance date for submitting drug master files (DMFs) in electronic common technical document (eCTD) format. Current deadline for submitting DMFs in eCTD format is May 5, 2018.
In order to reflect this change in the timeline, FDA has published Revision 4 of the Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. The compliance date for submitting NDAs, BLAs, and ANDAs electronically remains unchanged.
ASPHALION has extensive experience in transmitting electronic submissions using eCTD specifications. If you need any support to comply with FDA requirements, please contact us: [email protected]
