FDA Published a Draft Guidance on Drug Master Files

The FDA released on Oct 18th 2019 a draft guidance on Drug Master Files. The main objective of this guidance is to provide information regarding the preparation and submission of DMFs. It includes a description of the different DMF types, the information needed in DMF submissions, and the FDA’s review process. This document is intended to be a revision of the guidance for industry “Drug Master Files: Guidelines,” published in September 1989. 

The main features are the following:

• DMFs used in support of BLAs are added to the scope of the guidance.

• DP intermediates are added to the scope of Type II DMFs.

• Inclusion of data supporting protection, compatibility, and performance of a packaging material or container closure system for its intended useis no longer permitted in Type III DMFs. It is clarified that this type of information should be submitted within the application.