Issue Date: October 29, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Draft
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry
A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The draft guidance for industry Drug Master Files (October 2019) (hereinafter DMF guidance) and the DMF web page identify the types of DMFs that may be submitted. A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV.
Download the Guidance Document
