FDA has released tips on the submission of DMFs in eCTD format.
“There appears to be some confusion regarding when a Type III DMF (packaging material) should be submitted. It is not required that packaging information be submitted to the FDA in a DMF. The responsibility for providing information about packaging components rests foremost with the applicant of an NDA, ANDA or BLA, or the sponsor of an IND. This information may be provided to the applicant by the manufacturer of a packaging component or material of construction and may be included directly in the application. Any information that a manufacturer does not wish to share with the applicant or sponsor (i.e., because it is considered proprietary) may be placed in a Type III DMF and incorporated into the application by a letter from the manufacturer to the applicant which authorizes reference to the DMF.”
You can refer to the guidance (source) or contact us at [email protected] for more information.
Please be aware that as of 5 May 2018, Master File (MF) submissions must be in eCTD format.
Asphalion has extensive experience with eCTD publishing for DMFs. We can prepare the eCTD for you and submit directly from our offices on your behalf by the FDA Gateway.
