Response to Decision-Making with New Approach Methodologies: Time to Replace Default Uncertainty Factors with Data

Affiliations

• ¹ TERA, Cincinnati, Ohio 45223, USA.
• ² Emulate Inc., Boston, Massachusetts 02210, USA.
• ³ CFSAN, U.S. Food and Drug Administration, College Park, Maryland 20740, USA.
• ⁴ University of Sao Paulo, Sao Paulo, Brazil.
• ⁵ Brincor Associates, LLC, New Albany, Ohio 43054, USA.
• ⁶ College of Public Health, University of South Florida, Tampa, Florida 33612, USA.