An Interview With the Food and Drug Administration About Draft Patient-Focused Drug Development Guidance 3: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Jun 1, 2023, 00:00
10.1016/j.jval.2023.04.006
https://www.valueinhealthjournal.com/article/S1098-3015(23)02563-9/fulltext
Title :
An Interview With the Food and Drug Administration About Draft Patient-Focused Drug Development Guidance 3: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Citation :
https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(23)02563-9&doi=10.1016/j.jval.2023.04.006
First page :
791
Section Title :
INTERVIEW
Open access? :
No
Section Order :
791
The following interview provides Food and Drug Administration’s (FDA) responses to Value in Health’s clarification request on Draft Patient-Focused Drug Development (PFDD) Guidance 3: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The questions are based on ISPOR’s comments on the draft guidance and other topics that have emerged during open meetings and workshops. The interview was conducted by Elisabeth Oehrlein, PhD, MS, Associate Editor at Value in Health.
Categories :
- Clinical Outcomes
- Clinical Outcomes Assessment
- Clinician Reported Outcomes
- Patient-Centered Research
- Patient-reported Outcomes & Quality of Life Outcomes