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DIA Global Center

Oct 15, 2018 8:15 AM - Oct 16, 2018 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

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Session 13: Drug Master Files

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., 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

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