Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Training Course (US Eastern Time)

Jul 13, 2020 9:00 AM - Jul 16, 2020 2:00 PM

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

Back to Agenda

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

Have an account?