Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice
US FDA’s first guidance on patient data collection methods will be ready by June, and agency wants to get the tone right from the start; agency assures stakeholders it will be “flexible” on accepting new tools.
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At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.
Following stakeholder criticism of an earlier discussion paper, draft guidance does not automatically foreclose use of social media data as the primary source of qualitative research; however, agency says entities submitting such data for regulatory review must ensure rigor in methodology and data integrity.
With the disease-area meetings required under PDUFA V now behind it, FDA is turning its attention to guiding sponsors and advocacy groups on how to systematically collect patient experience data for use in drug development and regulatory decision-making. At least two guidance documents and a new data repository are on tap for 2018.