Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
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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.
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.
Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.