Topics
- Five types of DMFs and their uses
- Two FDA websites and three FDA guidance documents regarding DMFs
- 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files
- Drug Master Files (DMFs)
- Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances
- Drug Master Files: Guidelines
- Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
- When the DMF should be filed with the FDA
- Information to be contained in the DMF
- Checklist to construct a DMF from scratch
- Experiences of others regarding real world issues associated with creating and submitting DMFs
Who should Attend
Attendees from Regulatory Affairs, Manufacturing, Quality Assurance & Control, Research and Development, Development and Preparation of Submission Materials and Validation.
