| 1/7/2020 | CBER Vacancy: Senior Staff Fellow – Allergic Diseases |
| 1/6/2020 | Complete List of Licensed Products and Establishments |
| 1/6/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 1/6/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 1/6/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 1/2/2020 | Microparticles from sickle cell disease rbcs |
| 12/26/2019 | FY 2019 Report from the Director |
| 12/23/2019 | December 23, 2019 Approval Letter - Afluria and Afluria Quadrivalent |
| 12/23/2019 | BK190424 - IH-COM V5.2 |
| 12/23/2019 | Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry |
| 12/20/2019 | December 20, 2019 Approval Letter - MENVEO |
| 12/20/2019 | December 19, 2019 Approval Letter - ERVEBO |
| 12/20/2019 | Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document |
| 12/20/2019 | Important Information for Potential Donors of Blood and Blood Products |
| 12/20/2019 | TRG Rapid Inquiry Program (TRIP) |
| 12/20/2019 | BK190401 - ZipThaw™ 202 |
| 12/19/2019 | BK190400 - MTS™ Buffered Gel Card |
| 12/19/2019 | BK190399 - ORTHO VISION Max Analyzer |
| 12/19/2019 | Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry |
| 12/18/2019 | December 17, 2019 Approval Letter - MTS Anti-IgG Card |
| 12/18/2019 | December 17, 2019 Approval Letter - ORTHO Sera |
| 12/18/2019 | 2019 Biological Device Application Approvals |
| 12/18/2019 | 2019 Biological License Application Supplement Noteworthy Approvals |
| 12/16/2019 | BK190388 - TANGO infinity |
| 12/12/2019 | Meeting Transcript - Advancing Scientific and Regulatory Approaches for Use and Development of Biomarkers for Preventative Vaccines Meeting - Tuesday, September 17, 2019 |
| 12/12/2019 | BK190320 - DG Reader |
| 12/12/2019 | BK190321- WADiana Compact |
| 12/12/2019 | BK190318 - Erytra |
| 12/11/2019 | December 10, 2019 - Approval Letter - Anti-D (RH1) IgM/IgG 125621/2 |
| 12/11/2019 | December 10, 2019 Approval Letter - DG Gel 8 Anti-IgG (Rabbit), DG Gel Cards - STN# 125445/32 |
| 12/11/2019 | CBER Vacancy: Postdoctoral Fellow/Visiting Associate – Viral Vaccines (Biologist), RG-0401 |
| 12/9/2019 | Complete List of Licensed Products and Establishments |
| 12/9/2019 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 12/9/2019 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 12/9/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 12/9/2019 | December 6, 2019 Approval Letter - TENIVAC |
| 12/9/2019 | BK190333 - Terumo Operational Medical Equipment Software (TOMEs), Version 7.1 |
| 12/9/2019 | CBER-Regulated Products: Current Shortages |
| 12/6/2019 | Public Safety Notification on Exosome Products |
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