| 6/15/2022 |
June 15, 2022 Approval Letter - Procleix Ultrio Elite Assay |
| 6/15/2022 |
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry |
| 6/13/2022 |
Expiration Date Extension for 6 ASCENIV [Immune Globulin Intravenous, Human-slra, 10% Liquid] Lots manufactured in 2019 - 2020 |
| 6/10/2022 |
eSubmitter Download and Installation |
| 6/10/2022 |
BK210653 - ORTHO Daily QC Simulated Whole Blood Quality Control Kit |
| 6/9/2022 |
Coronavirus (COVID-19) | CBER-Regulated Biologics |
| 6/9/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate – Blood Borne Pathogens |
| 6/9/2022 |
Letter to Sponsors, Applicants and Regulated Entities on COVID-19 |
| 6/9/2022 |
eSubmitter Application History |
| 6/9/2022 |
June 8, 2022 Approval Letter – LUXTURNA |
| 6/8/2022 |
May17, 2021 Summary Basis for Regulatory Action - Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal |
| 6/8/2022 |
CBER-Regulated Products: Resolved Shortages |
| 6/7/2022 |
June 3, 2022 Approval Letter – Anti-Human Globulin and Blood Grouping Reagent (BL 103461/5118, et.al) |
| 6/6/2022 |
June 2, 2022 Approval Letter - Blood Grouping Reagents, Anti-Ds ((Monoclonal) (IgM), (Monoclonal) (IgM Blend) and (Monoclonal Blend)) |
| 6/6/2022 |
May 17, 2022 Summary Basis for Regulatory Action - DG Gel 8 Direct Coombs |
| 6/3/2022 |
June 3, 2022 Approval Letter – PRIORIX |
| 6/3/2022 |
June 2, 2022 Approval Letter - IPOL |
| 6/2/2022 |
CBER Vacancy: Bioinformatics Reviewer |
| 6/2/2022 |
Complete List of Licensed Products and Establishments |
| 6/2/2022 |
Complete List of Substantially Equivalent 510(k) Device Applications |
| 6/2/2022 |
Complete List of Currently Approved Premarket Approvals (PMAs) |
| 6/2/2022 |
Complete List of Currently Approved NDA and ANDA Application Submissions |
| 5/31/2022 |
May 27, 2022 Approval Letter - KYMRIAH |
| 5/31/2022 |
Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement |
| 5/26/2022 |
Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement |
| 5/26/2022 |
Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement |
| 5/26/2022 |
Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement |
| 5/26/2022 |
Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates |
| 5/26/2022 |
BK210631 - Sysmex XN-10 Automated Hematology Analyzer |
| 5/26/2022 |
May 20, 2022 Approval Letter - ANDEXXA |
| 5/25/2022 |
Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 |
| 5/24/2022 |
May 20, 2022 Approval Letter - Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal |
| 5/24/2022 |
May 20, 2022 Approval Letter - Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine Monoclonal |
| 5/24/2022 |
OTAT Learn |
| 5/24/2022 |
May 20, 2022 Approval Letter - DG Gel 8 Direct Coombs (Anti-IgG, -C3d) |
| 5/24/2022 |
May 20, 2022 Approval Letter - DG Gel 8 Direct Coombs (Anti-C3d) |
| 5/23/2022 |
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry |
| 5/23/2022 |
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry |
| 5/23/2022 |
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry |
| 5/20/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate - Biologist |
| 5/19/2022 |
Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338 |
| 5/19/2022 |
Regulatory Education for Industry (REdI) Annual Conference 2022 |
| 5/16/2022 |
May 12, 2022 Approval Letter - RYPLAZIM |
| 5/16/2022 |
2022 Biological License Application Supplement Noteworthy Approvals |
| 5/16/2022 |
2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals |
| 5/13/2022 |
HCT/P Inspections Performed in Fiscal Years 2017-2021 |
