Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
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US FDA Guidance On Endpoints Incorporating Clinical Outcome Assessments Fulfills Patient-Focused Commitment
Stakeholders can weigh in during 4 May 2023 webinar as US FDA rounds out a PDUFA VI commitment with a draft of the fourth of four methodological guidances on patient-focused drug development.
Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019
US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.