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FDA / CDC
FDA ADCOMs
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Type B & Type C Meetings
CRLs / FDRRs / MDLs
Label Negotiations
NDA / BLA / PMA Clinical Modules
ACIP & Work Group Meetings
IR Support
EMA-CHMP
Oral Explanations
SAG, AHEG & PRAC Meetings
Day 120 / 180 / 195 Questions
Clarification Meetings & Rapporteur Meetings
Strategic Communications
Message Evolution
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