Approval History, Letters, Reviews and Related Documents - RiaSTap

Proper Name: Fibrinogen Concentrate (Human)
Tradename: RiaSTAP
Manufacturer: CSL Behring GmbH, License # 1765
STN: 125317/0
Approval Date: January 16, 2009

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Approval information/letter/labeling

 

Memorandum/Reviews

• Summary Basis for Regulatory Action - RiaSTAP
• Analytical Procedures and Methods Memo - RiaSTAP
• BLA Recommendations - RiaSTAP
• Briefing Document - RiaSTAP
• Clinical Pharmacology Review - RiaSTAP [PDF Printable Version - 101 KB]
• FDA Briefing Document - RiaSTAP [PDF - 2 MB]
• Final CMC Review - RiaSTAP
• Facility Inspection Waiver Memo - RiaSTAP
• Final Review Memo (12/19/2008) - RiaSTAP
• Final Review Memo (12/17/2008) - RiaSTAP
• Final Review Memo (12/16/2008) - RiaSTAP
• First Committee Meeting Summary - RiaSTAP
• Mid-Cycle Meeting Summary - RiaSTAP
• Mid-Cycle Review Memo - RiaSTAP
• Mid-cycle Review Memo [PDF Printable Version - 6 MB] - RiaSTAP
• Pharmacology/Toxicology Review Memo - RiaSTAP
• Re-evaluation Memo - RiaSTAP
• Review of BLA - RiaSTAP
• Review Memo - Categorical Exclusion - RiaSTAP
• Review Memorandum - RiaSTAP
• Statistical Review and Evaluation - RiaSTAP

Correspondence

• 01/13/2009 Telecon - RiaSTAP
• 01/12/2009 Telecon - RiaSTAP
• 01/06/2009 Telecon - RiaSTAP
• 12/31/2008 Telecon - RiaSTAP
• 12/23/2008 Telecon - RiaSTAP
• 12/12/2008 Telecon - RiaSTAP
• 12/04/2008 Telecon - RiaSTAP
• 11/25/2008 Telecon - RiaSTAP
• 11/07/2008 Telecon - RiaSTAP
• 10/20/2008 Telecon - RiaSTAP
• 10/31/2008 Email [PDF Printable Version - 83 KB] - RiaSTAP
• 10/15/008 Fax [PDF Printable Version - 69 KB] - RiaSTAP
• 9/5/2008 Fax - RiaSTAP
• 08/25/ 2008 Email - RiaSTAP
• 08/18/ 2008 Email - RiaSTAP