| 3/27/2020 | Letter to Sponsors, Applicants and Regulated Entities on COVID-19 |
| 3/27/2020 | Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines |
| 3/26/2020 | Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions |
| 3/26/2020 | 2020 Biological License Application Supplement Noteworthy Approvals |
| 3/26/2020 | 2020 Biological Device Application Approvals |
| 3/26/2020 | TRG Rapid Inquiry Program (TRIP) |
| 3/24/2020 | March 23, 2020 Approval Letter - VAXELIS |
| 3/24/2020 | Investigational COVID-19 Convalescent Plasma - Emergency INDs |
| 3/23/2020 | March 20, 2020 Approval Letter - Typhim Vi |
| 3/23/2020 | Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19 |
| 3/20/2020 | March 20, 2020 Approval Letter - Fluarix Quadrivalent |
| 3/19/2020 | Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic |
| 3/18/2020 | Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays |
| 3/18/2020 | March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al. |
| 3/18/2020 | March 13, 2020 Approval Letter - ALBAclone STN#125309-64 |
| 3/16/2020 | eSubmitter Application History |
| 3/16/2020 | Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement |
| 3/13/2020 | Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms |
| 3/13/2020 | BK190430 - Anti-D Donor Management and Inventory System (ADIMS) |
| 3/13/2020 | BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports |
| 3/13/2020 | CBER-Regulated Products: Resolved Shortages |
| 3/12/2020 | Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes |
| 3/12/2020 | Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms |
| 3/12/2020 | Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry |
| 3/11/2020 | Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak |
| 3/11/2020 | BK190434 - ORTHO CONNECT 3.0 |
| 3/11/2020 | Regulatory Submissions - Electronic and Paper |
| 3/3/2020 | Complete List of Licensed Products and Establishments |
| 3/3/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 3/3/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 3/3/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 3/2/2020 | Statistical Review - FLUAD QUADRIVALENT |
| 3/2/2020 | February 20, 2020 Clinical Review - FLUAD QUADRIVALENT |
| 2/27/2020 | February 26, 2020 Approval Letter - ODACTRA |
| 2/25/2020 | Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting |
| 2/25/2020 | Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D) |
| 2/25/2020 | Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability |
| 2/25/2020 | Allergenic Products Advisory Committee May 15, 2020 Meeting Announcement |
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