The New FDA: Navigating New Policies and Managing ROI Risk

The cost of FDA approval or denial for pharmaceutical companies can be overwhelming. Combined with the astronomical cost of initial drug discovery R&D, it is no surprise that pharmaceutical companies often have trouble managing their ROI. It is imperative to include adequate controls in assessing drug efficacy for both preclinical animal studies and clinical trials. Doing so can mean the difference between approval and denial—which could mean the difference between billions of dollars of profit or debt.

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