Novartis and Genentech push for clarity from FDA on how disease progression models can be used for regulatory decisions
As companies continue their search for new drugs for debilitating diseases that progress over years and are notoriously tough to crack (think Alzheimer’s disease), the FDA is igniting a wider conversation on how and when the biopharma industry might be able to use specific models in their development programs.
The concept of disease progression models dates back for decades, and the FDA previously created a library of different models for diseases of public health importance, like Alzheimer’s, obesity and Parkinson’s disease.
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