Pediatric studies meeting
This article was originally published in The Tan Sheet
Executive Summary
Pediatric subcommittee of FDA's Anti-Infective Drugs Advisory Committee will meet in Bethesda, Md. June 11 to discuss list of drugs that have lost marketing exclusivity but need pediatric studies. Panel also will discuss a template for FDA "written requests" for pediatric studies of proton pump inhibitors in treating gastroesophageal reflux disease. AstraZeneca/P&G's NDA to switch the PPI Prilosec (omeprazole) OTC is focus of a joint Nonprescription Drugs/Gastrointestinal Drugs Advisory Committee meeting June 21 (1"The Tan Sheet" April 29, 2002, p. 3)...
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