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SESSION 5: POST-NDA APPROVAL REGULATORY REQUIREMENTS
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- Post-NDA approval obligations
- Post-marketing (phase 4) commitments
- Supplements and other changes to an approved application
- Post-marketing reporting of adverse drug experiences
- 15-day alert reports
- NDA annual reports
- PSUR/PBER/PADER
- NDA field alert reports
- Biologic product deviation reports
- FDA's Drug Registration and Listing System (DRLS)
Speaker(s)
POST-NDA APPROVAL REGULATORY REQUIREMENTS
Michael Hamrell, PHD, RAC
MORIAH Consultants, United States
President
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