Global Trial Accelerators™

Regulatory agencies across the Americas are implementing parallel reforms that could reshape FIH trial economics within 18 months, but the strategic implications vary significantly by jurisdiction and device classification:

• 🇧🇷 **ANVISA** cuts device trial timelines to **90 days** while launching mission registration protocols
• 🇲🇽 **COFEPRIS** pilot program targets reduced review periods as **Argentina** completes **62-day** framework overhaul
• 🌎 **PAHO** adaptive platform seminars signal coordinated regional approach while **FDA** tests real-time oversight models

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