Patient-Focused Drug Development Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments


The National Health Council (NHC) is pleased to provide comments on the Food and Drug Administration’s (FDA) discussion documents related to Guidance 2: “Methods to Identify What is Important to Patients” and Guidance 3: “Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments.” The NHC appreciates the work and thought that the FDA is putting into the development of these draft guidance documents.

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