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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
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