U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Cooperative Manufacturing Arrangements for Licensed Biologics
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry November 2008

Download the Final Guidance Document Read the Federal Register Notice
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.

>

Submit Comments

Submit Comments Online

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?

 
Back to Top