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Home » Sponsors Seek More Clarity in Draft Guidance on Patient-Focused Drug Development
Sponsors Seek More Clarity in Draft Guidance on Patient-Focused Drug Development
Multiple comments on the FDA’s efforts to provide guidance on how sponsors can develop patient-focused clinical outcome assessments (COA) for regulatory decision-making called for more clarity on one of the four types of COA — patient reported outcomes (PRO) — and on using digital health technology (DHT) for COA data.