I. Examine the Regulatory Application Approval Process
Discussion: Identify Key Issues for NDA Review from the FDA’s Perspective
II. Introduce the Common Technical Document (CTD)
Discussion: Can Using the CTD Format Address any of the NDA Review issues from the FDA’s
Perspective?
III. Explore CTD Module 1- Administrative Information and
Prescribing Information
Exercise: Prepare Module 1 from a Traditionally Formatted NDA
IV. Outline CTD Module 3 – Quality
Exercise: Prepare Module 3 from a Traditionally Formatted NDA
V. Describe CTD Module 4 – Non-Clinical Study Reports
Exercise: Prepare Module 4 from a Traditionally Formatted NDA
VI. Examine CTD Module 5 – Clinical Study Reports
Exercise: Prepare Module 5 from a Traditionally Formatted NDA
VII. Examine CTD Module 2 – Common Technical Document Summaries
VIII. Identify Best Practices for Speeding the Approval Process
Exercise: Perform Review of a Clinical Study Protocol and CMC submission from the FDA’s
Perspective and Discuss How to Improve
IX. Address the FDA’s Concerns to Improve Chances of Approval
Exercise: Develop a Risk Assessment with Mitigation and Contingency Plans for Addressing
the FDA’s Concerns
X. Explore eCTD Submission Opportunities: Software Packages and
Electronic Submission
XI. Evolve the CTD during FDA Review and After Approval
Exercise: Consider Possible Changes to the CTD and Discuss the Appropriate Filing Strategy
18(hours)