Issue Date: November 28, 2008
Issued by: Center for Biologics Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry
The development of complex and highly specialized technology and equipment for the manufacture of biological products has fostered the emergence of many companies that perform only limited aspects of manufacturing processes. Consequently, many manufacturers are interested in sharing or contracting parts of manufacturing in order to facilitate product development and manufacturing flexibility. Cooperative manufacturing arrangements enhance the development of new products.
Download the Guidance Document
