| 5/8/2020 | BK200478 - Aurora Xi Plasmapheresis System |
| 5/8/2020 | BK190313 - PK System Control |
| 5/8/2020 | May 7, 2020 Approval Letter - Reagent Red Blood Cells A1 Cells / B Cells |
| 5/8/2020 | May 7, 2020 Approval Letter - Blood Grouping Regents Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-D (PK 1), Anti-D (PK 2), Anti-E, Anti-e, Anti-C, Anti-c, and Anti-K |
| 5/8/2020 | BK180292 - PK7400 Automated Microplate System |
| 5/7/2020 | May 5, 2020 Approval Letter - VAXELIS |
| 5/6/2020 | April 27, 2020 Untitled Letter - Henry N. Small, MD, PA |
| 5/6/2020 | May 6, 2020 Approval Letter - HEPLISAV-B |
| 5/5/2020 | Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry |
| 5/4/2020 | May 1, 2020 Approval Order - INTERCEPT Blood System for Plasma |
| 5/4/2020 | April 28, 2020 Untitled Letter - BrioMD |
| 5/4/2020 | Complete List of Licensed Products and Establishments |
| 5/4/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 5/4/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 5/4/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 5/1/2020 | Investigational COVID-19 Convalescent Plasma; Guidance for Industry (Updated: May 1, 2020) |
| 5/1/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
| 4/30/2020 | Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19 (update) |
| 4/28/2020 | April 27, 2020 Untitled Letter - Infuze MD |
| 4/28/2020 | Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
| 4/27/2020 | BK200467- Erytra Eflexis |
| 4/27/2020 | April 10, 2020 Untitled Letter - Regenerative Solutions of New Jersey |
| 4/24/2020 | Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19 (update) |
| 4/24/2020 | CBER Vacancy: Staff Fellow/Visiting Associate: Viral Vaccines |
| 4/24/2020 | April 23, 2020 Approval Letter - MenQuadfi |
| 4/24/2020 | April 23, 2020 Approval Letter - Anti-D (RH1) IgM/IgG |
| 4/23/2020 | April 21, 2020 Approval Letter - AFSTYLA |
| 4/22/2020 | Clinical Investigator Status (Biologics) |
| 4/22/2020 | Coronavirus (COVID-19) | CBER-Regulated Biologics |
| 4/21/2020 | BK200456 - GeTraP |
| 4/20/2020 | April 10, 2020 Untitled Letter - Kimera Labs, Inc. |
| 4/16/2020 | Summary of Safety and Effectiveness-Elecsys HIV Duo |
| 4/16/2020 | 2020 Biological License Application Approvals |
| 4/16/2020 | 2020 Biological License Application Supplement Noteworthy Approvals |
| 4/16/2020 | 2020 Biological Device Application Approvals |
| 4/15/2020 | April 14, 2020 Approval Letter - FluMist |
| 4/10/2020 | April 10, 2020 Approval Letter - Elecsys HIV Duo |
| 4/9/2020 | Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2 |
| 4/9/2020 | User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
| 4/8/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
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