Allocate Full Doses of Agalsidase Beta (Fabrazyme®) to U.S. Citizens Under its Consent Decree with Genzyme Corporation

 
Docket ID: FDA-2011-P-0055
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: Closed Petition Denied 8/11/2014
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Allocate Full Doses of Agalsidase Beta (Fabrazyme®) to U.S. Citizens Under its Consent Decree with Genzyme Corporation
Keyword(s): Agalsidase Beta, Fabrazyme, Genzyme, CDER
Type: Nonrulemaking
Docket Status: Closed
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (5)
Comment Period Closed
Other
Posted: 08/11/2014
ID: FDA-2011-P-0055-0013
Comment Period Closed
Other
Posted: 08/04/2011
ID: FDA-2011-P-0055-0012
Comment Period Closed
Other
Posted: 07/18/2011
ID: FDA-2011-P-0055-0011
Comment Period Closed
Other
Posted: 02/08/2011
ID: FDA-2011-P-0055-0010

Supporting Documents

View All  (8)
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0055-0004
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0055-0009
Comments Not Accepted
Supporting & Related Material
Posted: 02/08/2011
ID: FDA-2011-P-0055-0007

Comments

 
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Comments Received*
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