This page has been updated recently.
- March 13, 2017 Summary Basis for Regulatory Action - Trumenba (PDF - 113KB)
Posted: 3/23/2017 - User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
Updated: 3/23/2017 - Summary Basis for Regulatory Action - Blood Grouping Reagents Anti-Jka, Anti-Jkb, Anti-K, Anti-P1, Anti-Fya, Anti-Fyb, Anti-S, Anti-s (PDF - 123KB)
Posted: 3/23/2017 - March 15, 2017 Summary Basis for Regulatory Action - ProQuad (PDF - 159KB)
Posted: 3/23/2017 - March 16, 2017 Approval Letter- PENTACEL (PDF - 33KB)
Posted: 3/23/2017 - March 1, 2017 Summary Basis for Regulatory Action - ODACTRA (PDF - 186KB)
Posted: 3/23/2017 - February 22, 2017 Summary Basis for Regulatory Action - RotaTeq (PDF - 66KB)
Posted: 3/23/2017 - Summary Basis for Regulatory Action - Anti-Fyb ALBsera (PDF - 113KB)
Posted: 3/23/2017 - March 15, 2017 Summary Basis for Regulatory Action - ZOSTAVAX (PDF - 159KB)
Posted: 3/23/2017
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