Back to Agenda
Session 22: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Elliott Berger, PHD, MS
President
ETB Regulatory Consulting, United States
- Post-NDA Approval Obligations
- Post-Marketing Requirements and Commitments
- Supplements and Other Changes to an Approved Application
- Post-Marketing Reporting
- NDA Annual Reports
- Other Post-Marketing Reports
Have an account?