학술논문
Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration.
Document Type
Article
Author
Source
Subject
*LEAN management
*COMBINATION drug therapy
*DRUG approval
*MANUFACTURING processes
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Language
ISSN
1752-8054
Abstract
The article focuses on the use of lean management methods to help the U.S. Food and Drug Administration (FDA) improves the process of reviewing combination products. Topics include the establishment of the FDA Office of Combination Products (OCP) in 2002 to enhance the transparency of combination product regulation, expected growth for the global market of combination products from 2012 to 2017, and development of the Intercenter Consult Request (ICCR) process.