The Evolution of Drug Master Files (DMFs)
|Event Date/Time: Mar 19, 2007||End Date/Time: Mar 19, 2007|
•FDA-recognized types of DMFs
•CDER and CBER processes and review of DMFs
•Roles/responsibilities for DMF holders and those who reference DMFs
•Methods of change control
•Suggested formats for DMFs
•Traditional vs. electronic DMFs.