Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability

Docket ID: FDA-2009-D-0539
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): cder200892, Therapeutic Proteins, Center for Biologics Evaluation and Research, Immunogenicity testing
Type: Nonrulemaking
Center: CDER
Docket Item Code: D

Primary Documents

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Comment Period Closed
Feb 02, 2010 11:59 PM ET
Posted: 12/04/2009
ID: FDA-2009-D-0539-0002
Comment Period Closed
Feb 02, 2010 11:59 PM ET
Posted: 12/04/2009
ID: FDA-2009-D-0539-0001

Supporting Documents

No documents available.


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Comments Received*
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