Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
You may also be interested in...
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.