US FDA's Patient Experience Data Guidance Calls More Attention To Burdens Of Surveys
Patient-focused drug development final guidance is little changed from 2019 draft but urges that quantitative data collection methods for issues important to patients need to easily usable by individuals with different abilities and cultural backgrounds.
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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 listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.