Agenda
9:00 AM — 9:30 AM
9:30 AM — 9:40 AM
9:40 AM — 10:30 AM
Session 1: Opening Remarks11:15 AM — 11:30 AM
11:30 AM — 12:15 PM
Session 3: Comparative Analytical Data Expectations12:15 PM — 1:00 PM
Session 4: Comparative Clinical Data Expectations1:00 PM — 2:00 PM
2:00 PM — 2:45 PM
Session 5: Chemistry, Manufacturing, and Controls (CMC)2:45 PM — 3:30 PM
Session 6: Strategies for Successful 351(k) BLA Regulatory Submissions3:30 PM — 3:45 PM
3:45 PM — 4:30 PM
Session 7: Quality Assessment Review4:30 PM — 5:00 PM
Session 8: TBD5:00 PM — 5:15 PM
10:00 AM — 10:10 AM
10:10 AM — 11:00 AM
Session 1: Pre-License and Pre-Approval Inspections11:00 AM — 11:45 AM
Session 2: 351(k) BLA Post Approval Changes11:45 AM — 12:00 PM
12:00 PM — 12:30 PM
Session 3: FDA’s Outreach/Educational Materials, and Online Resources12:30 PM — 1:00 PM
Session 4: Additional Application Considerations1:00 PM — 2:00 PM
2:00 PM — 2:45 PM
Session 5: TBD2:45 PM — 3:00 PM
3:00 PM — 3:45 PM
Session 6: Ask Me Anything3:45 PM — 4:15 PM
Session 7: Closing Remarks & ThanksHave an account?