The International Neonatal Consortium: collaborating to advance regulatory science for neonates

As dened by the US Food and Drug Administration (FDA), regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products (1). Nowhere is the need greatest for such standardized methods and new approaches than for the regulation of medicines for neonates (2). Recognizing that researchers oen generate results that may inuence regulatory decision making, yet are not steeped in the rigorous scientic requirements for regulatory review, the Innovative Medicines Initiative recently released a guidance tool for researchers about how to access support from regulators (3,4).