title: Biologics for inflammatory bowel disease: drug approval and monitoring in the United States.
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.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, 200 1st Street, SW, Rochester, MN 55905, USA. tremaine.william@mayo.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Tremaine
mesh_terms: D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000592:standards; D017277:Drug Approval; D016903:Drug Monitoring; D028744:Ethics Committees, Research; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000628:therapy*; D009965:Orphan Drug Production / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States
chemical_list: D001688:Biological Products