| 9/2/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
| 9/2/2020 | Investigational COVID-19 Convalescent Plasma; Guidance for Industry |
| 9/2/2020 | Complete List of Licensed Products and Establishments |
| 9/2/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 9/2/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 9/2/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 8/27/2020 | Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement |
| 8/27/2020 | August 27, 2020 Approval Letter - Afluria |
| 8/27/2020 | Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry |
| 8/26/2020 | Influenza Vaccine for the 2020-2021 Season |
| 8/26/2020 | Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry |
| 8/23/2020 | Coronavirus (COVID-19) | CBER-Regulated Biologics |
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| 8/23/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
| 8/23/2020 | Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020 |
| 8/21/2020 | August 20, 2020 Approval Letter - Gardasil 9 |
| 8/20/2020 | 2020 Biological Device Application Approvals |
| 8/20/2020 | 2020 Biological License Application Approvals |
| 8/20/2020 | Clinical Review - XYNTHA |
| 8/20/2020 | Statistical Review - XYNTHA |
| 8/19/2020 | Influenza Vaccine for the 2020-2021 Season |
| 8/19/2020 | eSubmitter Application History |
| 8/19/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
| 8/18/2020 | Updated Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines |
| 8/17/2020 | August 13, 2020 Approval Letter - XYNTHA |
| 8/17/2020 | August 14, 2020 Approval Letter - RotaTeq |
| 8/14/2020 | Novel Methods to Detect Malaria Biomarkers for Evaluation of Vaccine Safety and Efficacy |
| 8/14/2020 | Immunogenicity of Gene Therapy Products |
| 8/14/2020 | August 12, 2020 Summary of the Safety and Effectiveness - cobas HIV-1/HIV-2 Qualitative |
| 8/13/2020 | August 12, 2020 Approval Order - cobas HIV-1/HIV-2 Qualitative |
| 8/13/2020 | August 11, 2020 Untitled Letter - East West Health Solutions, Inc. |
| 8/12/2020 | July 23, 2020 Summary Basis for Regulatory Action - TECARTUS |
| 8/12/2020 | Influenza Vaccine for the 2020-2021 Season |
| 8/12/2020 | CBER-Regulated Products: Resolved Shortages |
| 8/11/2020 | Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement |
| 8/7/2020 | BK200449 – Healeon Duet |
| 8/5/2020 | Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines |
| 8/5/2020 | Influenza Vaccine for the 2020-2021 Season |
| 8/4/2020 | Complete List of Licensed Products and Establishments |
| 8/4/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 8/4/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 8/4/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 8/3/2020 | BK200491 - iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0 |
| 8/3/2020 | Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations |
| 8/3/2020 | MedWatch to Manufacturer Program |
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