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Generics: Getting Beyond “File First, Figure it Out Later”
Agnes Shanley
Agnes Shanley is senior editor of Pharmaceutical Technology.
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.
Read this article in Pharmaceutical Technology’s September 2019 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 24–26
Citation
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).