Electronic Submissions: A Medical Reviewer’s Perspective
Objectives
Reviewer Feedback - eNDA
Survey Questions
eNDA Feedback
Advantages - Top 5
Advantages - Other Comments
Disadvantages - Top 5
Disadvantages - Other Comments
Conclusions
Personal DO’s and DON’Ts
Bookmarks
Hypertext Links
Labeling
Scanned Images
Define.pdf
Datasets
Datasets - File Size
Splitting Datasets
DO Follow the Guidances
Home Page: www.fda.gov/cder/regulatory/ersr/default.htm