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
Abstract
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 The questions are based on ISPOR’s comments on the draft guidance and other topics that have emerged during open meetings and workshops.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.
Authors
Elisabeth M. Oehrlein Robyn Bent Fraser Bocell Lili Garrard Laura Lee Johnson Naomi Knoble David Reasner Michelle Tarver Kevin Weinfurt Theresa Mullin