About the Authors

Kirk W. Kerr

Roles Conceptualization, Data curation, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing

Kirk.kerr@fda.hhs.gov

Affiliation Office of Program and Strategic Analysis, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD United States of America

Thomas C. Henry

Roles Data curation, Investigation, Methodology, Writing – review & editing

Affiliation Office of Planning, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD United States of America

Kathleen L. Miller

Roles Conceptualization, Investigation, Methodology, Writing – original draft, Writing – review & editing

Affiliations Office of Orphan Products Development, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD United States of America, Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC United States of America

Competing Interests

The authors have declared that no competing interests exist.