Posted: 6/14/2019
Posted: 6/14/2019
| 6/17/2019 | June 14, 2019 Approval Letter - Alinity s HBsAg and Alinity s HBsAg Confirmatory |
| 6/17/2019 | 2019 Biological Device Application Approvals Updated as of 5/31/2019 |
| 6/17/2019 | 2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals Updated as of 5/31/2019 |
| 6/17/2019 | 2019 Biological License Application Approvals Updated as of 5/31/2019 |
| 6/14/2019 | May 24, 2019 Summary Basis for Regulatory Action - ZOLGENSMA |
| 6/14/2019 | CBER Vacancy - Staff Fellow: Computer Scientist (RG-1550) |
| 6/13/2019 | Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms |
| 6/13/2019 | Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry |
| 6/13/2019 | CBER-Regulated Products: Current Shortages Information on APLISOL |
| 6/12/2019 | June 11, 2019 Approval Letter - Quadracel |
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