Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Regulatory watch

Characterizing the US FDA's approach to promoting transformative innovation

This is a preview of subscription content, access via your institution

Access options

Buy article

Get time limited or full article access on ReadCube.

$32.00

All prices are NET prices.

Figure 1: Characteristics of novel therapeutics approved by the FDA between 2005 and 2012, stratified by degree of innovation.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Joseph S. Ross.

Ethics declarations

Competing interests

H. Krumholz and J. Ross are funded by research agreements through Yale University from Medtronic and Johnson & Johnson (Janssen) to develop methods of clinical trial data sharing, by the US Centers for Medicare & Medicaid Services to develop and maintain performance measures, and by the US Food and Drug Administration to develop methods for post-market surveillance of medical devices. H. Krumholz chairs a cardiac scientific advisory board for UnitedHealth. The other authors do not have competing interests to report.

Additional information

This research was not supported by any external grants or funds.

Related links

PowerPoint slides

Supplementary information

Supplementary information S1 (box)

Data and analysis (PDF 449 kb)

Supplementary information S2 (figure)

Novel therapeutics approved by the FDA between 2005 and 2012 and their degree of innovation, stratified by drug type and therapeutic area. (PDF 113 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Downing, N., Krumholz, H., Ross, J. et al. Characterizing the US FDA's approach to promoting transformative innovation. Nat Rev Drug Discov 14, 740–741 (2015). https://doi.org/10.1038/nrd4734

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd4734

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing