Regulatory review of new product innovation (NPI) has come to dominate contemporary discourse on innovation management. However, there continue to be a lack of clarity on how normative and scientific logics of evaluation combine to influence the regulatory review process. To bring some much-needed clarity, we draw on the diverse literature streams on regulatory reviews and NPI to unpack how the regulatory review process may play out in practice. We then explicate four varieties of regulatory review concerns that frequently affect regulatory decisions: speed and delays, safety and efficacy, cost and uncertainty, and routines. We go further to present eight propositions regarding these concerns to extend our understanding on how they may constitutively influence regulators decisions in articulating the value of NPIs and their potential to shaping innovation trajectories. We conclude by outlining and highlighting rich opportunities for future research.
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