Better Modeling Through PDUFA

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

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.

Innovative trial designs could be a key to reducing drug development timelines and cost.

The approach to MIDD and complex trial designs show how drug user fee negotiations have evolved from adversarial negotiations over review deadlines and efforts by industry to script the minutia of regulatory interactions. The narrative now is driven by broader discussions over industry-FDA cooperation to advance regulatory science.

The shift reflects a grudging recognition by industry negotiators that they have little leverage to impose new deadlines and their acceptance of FDA's contention that it will perform better when given sufficient resources and flexibility about how it achieves the agreed upon goals. These concessions are reflected

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