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.
You may also be interested in...
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.
Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.
US agency will hold five workshops and develop seven guidance documents focused on patient input in the drug development and review process; since some guidance requirements under Cures law overlap with those in PDUFA VI commitment letter, most of the funding will come from user fees.