An Update on Drug Master File Agency Activities
Recommendations for Improvements to the Drug Master File System
Improvements to the Drug Master File System (cont)
Elimination of Type I DMFs
Elimination of Type I DMFs (cont)
Electronic DMF Project (Excalibur)
Improve MIS DMF System
Consistent Review Policy for Type II DMFs
DMF Cover Form
Type II DMF Review Form
Re-review Policy
Re-review Policy (cont)
Review Policy
DMF Guideline Revision
Email: shawa@cder.fda.gov
Home Page: http://www.fda.gov/cder