BioCentury
ARTICLE | Regulation

Better Modeling Through PDUFA

How PDUFA VI could improve drug development via better models, innovative trials

August 8, 2016 7:00 AM UTC

During negotiations over PDUFA VI FDA and industry agreed on initiatives to advance the agency's capability to accommodate "model-informed drug development" and novel clinical trial designs, two domains that could dramatically improve the speed and outcomes of clinical development. Biopharma companies and FDA also have agreed to take another bite at biomarkers.

Improving model-informed drug development (MIDD) could help sponsors avoid some of the mistakes that most commonly lead to rejections of first-time drug applications, especially uncertainties related to dose selection, the choice of endpoints that do not reflect clinical benefit, and improper dosing for specific populations...