You could be reading the full-text of this article now if you...

If you have access to this article through your institution,
you can view this article in

Drug development in inflammatory bowel disease: The role of the FDA

Lahiff, Conor MB1; Kane, Sunanda MD, MSPH2; Moss, Alan C. MD, FACG1,*

Inflammatory Bowel Diseases:
doi: 10.1002/ibd.21712
Clinical Reviews
Abstract

Abstract:: All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench‐marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.

Author Information

1 Center for Inflammatory Bowel Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts

2 Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota

*Reprints: Center for Inflammatory Bowel Disease, BIDMC, 330 Brookline Ave., Boston MA 02215

Email: amoss@bidmc.harvard.edu

Received 9 February 2011; Accepted 21 February 2011

Published online 11 April 2011 in Wiley Online Library (wileyonlinelibrary.com).

© Crohn's & Colitis Foundation of America, Inc.

You currently do not have access to this article.

You may need to:

Note: If your society membership provides for full-access to this article, you may need to login on your society’s web site first.