FDA releases next guidance in patient-focused drug development series

FDA released draft guidance on Thursday to encourage industry and other stakeholders to submit proposed draft guidances for incorporating patient experience data into product development and regulatory decisions.

The agency said stakeholders could submit their own draft guidances if existing clinical or methodological guidances do not address a specific subpopulation and when patient data could inform drug development for a disease for which no disease-specific guidance exists. The agency said a stakeholder-submitted draft guidance could be used to inform FDA's decision-making and future guidance development work...