Approval History, Letters, Reviews and Related Documents - Seraclone Anti-s (Monoclonal)

Proper Name: Blood Grouping Reagent Anti-s (Monoclonal)
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH
STN: 125214/0
Approval Date: August 14, 2008

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Approval information/letter/labeling

 

Memorandum/Reviews

• Summary Basis for Regulatory Action

• Review Memo - Biotest AG, license number 1702. Response (submitted November 30, 2007) to our CR letter (issued July 30, 2007)
• Review Memo - Biotest AG’s Blood Grouping Reagents
• Review Memo and Recommendation - Biotest AG’s Blood Grouping Reagents Anti-Fy^a (Monoclonal) and Anti-s (Monoclonal)
• Review Letter - Amendments to BLA
• Request to Waive Memo - STN 125214/0 from referral to Blood Products Advisory Committee
• Recommend Memo - Recommendation to Waive Pre-Approval Inspection
• Review Memo - Categorical Exclusion under 21 CFR 25.31(c)
• Review Letter - Submissions dated November 30, 2007 ( PDF - 104 KB)
• Review Memo - Original Application / Prior Approval Supplement (PDF - 135 KB)
• Review Memo - Manufacturing Summary (PDF - 100 KB)
• Review Letter - Deficiencies in CMC/CLINCAL/STATISTICS/LABELING/OTHER (PDF - 94 KB)
• Review Memorandum (PDF - 226 KB)
• Review Memorandum dated February 14, 2007 (PDF - 128 KB)
• Review of BLA - Blood Grouping Reagents, July 27, 2007 (PDF - 101 KB)
• Review of BLA - Blood Grouping Reagents, January 31, 2008 (PDF - 44 KB)

 

Administrative Documents

Officer/Employee List

 

Correspondence

• 8/5/2008 Telecon
• 1/14/2008 Telecon