Healthy Skepticism Library item: 8741

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Publication type: Journal Article

Tremaine WJ.
Biologics for inflammatory bowel disease: drug approval and monitoring in the United States.
Gastroenterol Clin North Am 2006 Dec; 35:(4):735-41
http://www.gastro.theclinics.com/article/PIIS0889855306000860/fulltext

Abstract:

Biologics are a primary focus for research and development of new treatments for IBD and other immune disorders. CDER, which is a branch of the FDA, oversees most of the biologics that are being used or tested for IBD, and it regulates nonbiologic medications for IBD. The approval process for most biologics for IBD is similar to the process for nonbiologics. FDA regulation of a new drug or biologic can be divided into three stages: the commercial IND, the NDA, and postmarketing (phase 4) studies. It is unclear if generic versions of biologics can be approved within the current legislation.

Keywords:
Publication Types: Research Support, Non-U.S. Gov't Review MeSH Terms: Biological Products/standards* Biological Products/therapeutic use Clinical Trials/standards Drug Approval* Drug Monitoring* Ethics Committees, Research Humans Inflammatory Bowel Diseases/therapy* Orphan Drug Production/standards Product Surveillance, Postmarketing/standards United States Substances: Biological Products