Agenda
12:30 PM — 1:00 PM
1:00 PM — 1:15 PM
INTRODUCTION TO NDA PART1:15 PM — 2:15 PM
SESSION 1: THE NDA IN CTD FORMAT2:15 PM — 3:00 PM
SESSION 2: THE NDA IN CTD FORMAT: WHAT IS A CTD?3:00 PM — 3:15 PM
3:15 PM — 4:45 PM
SESSION 3: THE NDA IN CTD FORMAT (CONTINUED)4:45 PM — 5:45 PM
8:00 AM — 9:00 AM
SESSION 4: HOW TO SUBMIT A NDA AND ACTION ON APPLICATIONS9:00 AM — 10:00 AM
SESSION 5: POST-NDA APPROVAL REGULATORY REQUIREMENTS10:00 AM — 10:15 AM
10:15 AM — 11:15 AM
SESSION 6: NDA POST-APPROVAL WORKSHOP11:15 AM — 12:15 PM
SESSION 7: INTERACTIONS WITH FDA12:15 PM — 1:15 PM
1:15 PM — 3:00 PM
SESSION 8: MOCK FDA MEETING3:00 PM — 3:15 PM
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