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GUIDANCE DOCUMENT

Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components October 2006

Final

Docket Number:: FDA-2001-D-0008
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

1

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-2001-D-0008.

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