Deadline for eCTD Submissions for DMFs Around the Corner
The Food and Drug Administration's (FDA) requirement for Electronic Common Technical Document (eCTD) formatting for all submissions associated with drug applications, including Drug Master Files (DMFs), is scheduled to become effective on May 5, 2018.
Stakeholders in the drug packaging area have asked FDA to allow waivers or exemptions to this requirement for Type III DMFs (i.e., DMFs for packaging materials) or, at a minimum, to extend the deadline. However, FDA has not provided a definitive response to this request, and as the clock keeps ticking, relief from the eCTD requirement appears less and less likely.
As your company considers ways to address this new requirement, please keep in mind that Keller and Heckman LLP has taken the lead on capability and experience in filing DMF submissions in eCTD format and we would be happy to assist.