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6. Contemplating what we have heard today, what do we think we know about what works and what does not, and what would be the most useful things that could/should happen next?

GENERAL DISCUSSION and CHAIRMAN'S SUMMARY

5:30 ADJOURN

Tuesday, February 11th

8:30 MEETING RESUMES

ELEMENT 4: Discussion Panel, FDA and Industry Representatives

7. Current Legal/Regulatory Issues Around Development of Drugs and Vaccines for Emerging Infections

  • Antimicrobial Resistance and Labeling
  • Combination Products: Vaccines and Pharmaceuticals
  • Special Mechanisms to Expedite Approval (e.g., fast-track mechanisms)
  • Use of Foreign Data/ICH Activities
  • Product Availability

From the Food and Drug Administration:

Elaine Esber

Mark Goldberger

Jeffrey Murray

Stuart Nightingale

From the Forum on Emerging Infections: Member Representatives from Industry

10:30 ADJOURN



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