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

Value Health. 2023 Jun;26(6):791-795. doi: 10.1016/j.jval.2023.04.006. Epub 2023 Apr 26.

Authors

Elisabeth M Oehrlein¹; US Food and Drug Administration Interviewees²

Collaborators

US Food and Drug Administration Interviewees:
Robyn Bent, Fraser Bocell, Lili Garrard, Laura Lee Johnson, Naomi Knoble, David Reasner, Michelle Tarver, Kevin Weinfurt, Theresa Mullin

Affiliations

¹ Applied Patient Experience, Washington, DC, USA. Electronic address: eoehrlein@appliedpx.com.
² Applied Patient Experience, Washington, DC, USA.

PMID: 37116698
DOI: 10.1016/j.jval.2023.04.006

No abstract available

Publication types

Interview
Editorial

MeSH terms

Data Collection
Drug Approval
Drug Development*
Humans
Outcome Assessment, Health Care*
United States
United States Food and Drug Administration