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GUIDANCE DOCUMENT

Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry November 2008

Final
Docket Number:
FDA-1999-D-0128
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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.

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Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0128.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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