Precision Medicine, Molecular Diagnostics and Clinical Utility

A funny thing happened in the race to realize the substantial benefits of precision medicine: healthcare payer reluctance to reimburse for testing with molecular diagnostics until there is evidence connecting test results with improved patient outcomes. On the one hand, we are witnessing rapid progress in identification of biomarkers and development of related assays. On [...]

Precision Medicine, Molecular Diagnostics and Clinical Utility 2017-09-05T21:39:37+00:00

Expedited Development for All: the Phase 2c Pathway

FDA's Expedited Programs for Serious Conditions, as well as the Orphan Drug Designation, remain exceptional by design. However, the time has come to consider ways of transforming the exception into the rule: providing the benefits of expedited programs beyond products for serious conditions with unmet medical needs. The success of FDA's expedited programs demonstrates that [...]

Expedited Development for All: the Phase 2c Pathway 2018-04-30T15:26:47+00:00
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