| 6/1/2020 | Complete List of Licensed Products and Establishments |
| 6/1/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 6/1/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 6/1/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 5/28/2020 | Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
| 5/27/2020 | May 14, 2020 Approval Letter - CUTAQUIG |
| 5/27/2020 | May 18, 2020 Approval Letter - YESCARTA |
| 5/22/2020 | Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens |
| 5/21/2020 | BK200472 - BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle |
| 5/21/2020 | HCT/P Inspection Information |
| 5/19/2020 | Annual Summary for Fiscal Year 2019 |
| 5/19/2020 | Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry |
| 5/18/2020 | 2020 Biological License Application Approvals |
| 5/18/2020 | 2020 Biological Device Application Approvals |
| 5/14/2020 | April 28, 2020 Untitled Letter - ValeoMD |
| 5/14/2020 | May 13, 2020 Approval Letter - FLUAD |
| 5/14/2020 | April 22, 2020 Summary Basis for Regulatory Action - MenQuadfi |
| 5/13/2020 | May 12, 2020 Approval Letter - Flublok |
| 5/12/2020 | May 11, 2020 Untitled Letter - Sparrow Health & Performance, LLC |
| 5/12/2020 | Transcript for the Facilitating End-to-End Development of Individualized Therapeutics Public Workshop |
| 5/12/2020 | May 11, 2020 Approval Letter - Anti - M (Murine Monoclonal IgG) STN#125308-56 |
| 5/12/2020 | eSubmitter Application History |
| 5/11/2020 | Updated Information for Blood Establishments Regarding the Novel Coronavirus (COVID-19) Outbreak |
| 5/11/2020 | CBER-Regulated Products: Resolved Shortages |
| 5/10/2020 | May 7, 2020 Approval Letter - Blood Grouping Reagent Anti-e P3GD512 + MS16 + MS21 + MS63 |
| 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 |
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