NIH: FDA key for speed and safety

Reichmann, James P.

doi:10.1038/474161c

Correspondence
Published: 08 June 2011

NIH: FDA key for speed and safety

James P. Reichmann¹

Nature volume 474, page 161 (2011)Cite this article

633 Accesses
2 Citations
Metrics details

Subjects

Access through your institution

Buy or subscribe

The US National Institutes of Health (NIH) and the Food and Drug Administration (FDA) should work together to bring products to market (Nature 471, 135; 2011). A telling example reveals how well this can work.

In the early 2000s, the National Institute of Child Health and Human Development conducted clinical trials of 17P, a drug that successfully reduced pre-term birth by more than 30% in women who had experienced it previously (P. J. Meis et al. N. Engl. J. Med. 348, 2379–2385; 2003). The FDA granted the drug orphan status in 2003 to motivate the pharmaceutical company behind 17P to apply for FDA approval, which was granted this year after using the same NIH trial for the approval process.

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

Access options

Access through your institution

Buy this article

Purchase on SpringerLink
Instant access to full article PDF

Buy now

Prices may be subject to local taxes which are calculated during checkout

Author information

Authors and Affiliations

American HomePatient, Tennessee, USA
James P. Reichmann

Authors

James P. Reichmann
View author publications
Search author on:PubMed Google Scholar

Corresponding author

Correspondence to James P. Reichmann.

Additional information

Rights and permissions

Reprints and permissions

About this article

Cite this article

Reichmann, J. NIH: FDA key for speed and safety. Nature 474, 161 (2011). https://doi.org/10.1038/474161c

Download citation

Published: 08 June 2011
Issue date: 09 June 2011
DOI: https://doi.org/10.1038/474161c