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A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.
Generic pharmaceuticals now account for more than 90% of all prescriptions issued in the United States. However, the generic pharmaceuticals’ pipeline flow is anything but smooth. A report issued on Aug. 7, 2019 by the US Government Accountability Office (GAO) (1) traces part of the problem to issues with FDA review. A New Prior Knowledge” concept that would make crucial process and product information available has been proposed by the National Institute for Pharmaceutical Technology and Education.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as A. Shanley, “Generics: Getting Beyond ‘File First, Figure it Out Later’," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).