Informatics in Medical Product Regulation: The Right Drug at the Right Dose for the Right Patient.

This chapter describes the role of regulatory medical product review in furthering precision medicine. Efficient data processing and appropriate analyses are needed to synthesize information and provide directions for use in a medical product label. We describe opportunities and challenges in outcome assessment through informatics, as bioengineered therapeutics are increasingly developed for the unmet needs of molecularly defined diseases. Data submission requirements and analytic principles are outlined, and regulatory resources and foundational law and statute are cited for the reader.