On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting information from patients and caregivers in order to use it to develop medical products under the agency's patient-focused drug development initiative (PFDD).
In the final guidance, the agency clarifies how the industry can interact early with the agency in order to get feedback on patient experience data.
This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development (PFDD) guidance documents.
The methods described in this document can be used to elicit what is important to patients, which may in turn help inform understanding of disease/condition and clinical trial design.
It may also help the generation and use of patient experience data, including clinical outcome assessments and patient preference information, to inform benefit-risk assessment.
Click on this LINK to Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
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