- Fast Track Designation Request Performance
Updated: 1/30/2019 - Malaria gene activity findings could form basis of improved test for monitoring disease spread
Posted: 1/30/2019 - BK180258 - Vista Information System
Posted: 1/30/2019 - BK180280 - DG Gel Essential Control
Posted: 1/29/2019 - eSubmitter Application History
Updated: 1/29/2019
Recently Added
- Fast Track Designation Request Performance
Updated: 1/30/2019 - Malaria gene activity findings could form basis of improved test for monitoring disease spread
Posted: 1/30/2019 - BK180258 - Vista Information System
Posted: 1/30/2019 - BK180280 - DG Gel Essential Control
Posted: 1/29/2019 - eSubmitter Application History
Updated: 1/29/2019 - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Information on TICE BCG - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Dialysis formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Pediatric/Adolescent formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Adult formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on SHINGRIX - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Information on Cuvitru December 21, 2018 Approval Letter - VAXELIS (PDF - 54KB)
Posted: 12/21/2018December 21, 2018 Approval Letter - Recombivax HB (PDF - 35KB)
Posted: 12/21/2018December 20, 2018 Approval Letter - ActHIB (PDF - 33KB)
Posted: 12/21/2018December 12, 2018 Summary Basis for Regulatory Action - CUTAQUIG (PDF - 224KB)
Posted: 12/21/2018December 20, 2018 Approval Letter - VAQTA (PDF - 33KB)
Posted: 12/21/2018December 20, 2018 Approval Letter Diphtheria and Tetanus Toxoids Adsorbed 103944 (PDF - 32KB)
Posted: 12/20/2018December 19, 2018 Approval Letter - ENGERIX-B (PDF - 37KB)
Posted: 12/20/2018Letter regarding FDA's regenerative medicine framework and enforcement discretion period for HCT/Ps (PDF - 95KB)
Posted: 12/20/2018Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry (PDF - 135KB)
Posted: 12/20/2018- Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements
Posted: 12/20/2018 December 19, 2018 Approval Letter - Havrix (PDF - 33KB)
Posted: 12/20/2018
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