Gastroenterology
Reports on gastroenterology findings from College of Medicine provide new insights
Published in Medical Letter on the CDC and FDA, January 28th, 2007
Data detailed in "Biologics for inflammatory bowel disease: drug approval and monitoring in the United States" have been presented. According to a study from the United States, "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)...
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