Unmet needs: Research helps regulators do their jobs

Russ B Altman; Natalia Khuri; Marc Salit; Kathleen M Giacomini

doi:10.1126/scitranslmed.aac4369

Unmet needs: Research helps regulators do their jobs

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

Authors

Russ B Altman¹, Natalia Khuri², Marc Salit³, Kathleen M Giacomini⁴

Affiliations

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.

PMID: 26606966
DOI: 10.1126/scitranslmed.aac4369

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.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Review

MeSH terms

Cell- and Tissue-Based Therapy
Clinical Trials as Topic
Drug Approval
Equipment and Supplies
Health Services Needs and Demand*
Humans
Nanostructures
Research*
United States

Grants and funding

U01FD004979/FD/FDA HHS/United States