Sci Transl Med. 2015 Nov 25;7(315):315ps22. doi: 10.1126/scitranslmed.aac4369.

Unmet needs: Research helps regulators do their jobs.

Altman RB¹, Khuri N², Salit M³, Giacomini KM⁴.

Author information

1: Department of Genetics, Stanford University, Stanford, CA 94305, USA.
2: Department of Bioengineering, Schools of Engineering and Medicine, Stanford University, Stanford, CA 94305, USA. Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, CA 94143-2911, USA.
3: Department of Bioengineering, Schools of Engineering and Medicine, Stanford University, Stanford, CA 94305, USA. Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA.
4: Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, CA 94143-2911, USA. Institute for Human Genetics, University of California San Francisco, San Francisco, CA 94143, USA. kathy.giacomini@ucsf.edu.

Abstract

A plethora of innovative new medical products along with the need to apply modern technologies to medical-product evaluation has spurred seminal opportunities in regulatory sciences. Here, we provide eight examples of regulatory science research for diverse products. Opportunities abound, particularly in data science and precision health.