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Session 9: Drug Master Files (DMF)
Session Chair(s)
Priya Jambhekar
President
PBS Regulatroy Consulting Group, United States
- Regulatory Basis
- DMF Submissions
- Transmittal Letter
- Administrative Information
- FDA Review of DMFs
- Types I, II, III, IV, and V DMFs
- General Suggestions
- Letters of Authorization
- Holder Obligations
- Transfer of Ownership and Potential Issues