| 1/30/2020 | Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry |
| 1/29/2020 | January 28, 2020 Approval Letter - Agriflu |
| 1/28/2020 | Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry |
| 1/28/2020 | Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry |
| 1/28/2020 | Human Gene Therapy for Retinal Disorders; Guidance for Industry |
| 1/28/2020 | Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry |
| 1/28/2020 | Human Gene Therapy for Rare Diseases; Guidance for Industry |
| 1/28/2020 | Human Gene Therapy for Hemophilia; Guidance for Industry |
| 1/28/2020 | Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry |
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| 1/24/2020 | January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY |
| 1/24/2020 | January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent |
| 1/23/2020 | January 22, 2020 Approval Letter - DENGVAXIA |
| 1/22/2020 | BK190439 - MATCH IT! DNA (version 1.3) |
| 1/22/2020 | 2019 Biological Device Application Approvals |
| 1/22/2020 | 2019 Biological License Application Supplement Noteworthy Approvals |
| 1/22/2020 | 2019 Biological License Application Approvals |
| 1/17/2020 | Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement |
| 1/15/2020 | December 19, 2019 Summary Basis for Regulatory Action - ERVEBO |
| 1/13/2020 | CBER Vacancy: Physician, Division of Epidemiology (DE) |
| 1/10/2020 | Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Transcript |
| 1/10/2020 | January 8, 2020 Approval Letter - GRASTEK |
| 1/9/2020 | CBER-Regulated Products: Current Shortages |
| 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 |
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