| 7/18/2022 |
BK210584 - Genesis RapidWeld II STW, model GRW-430-02 |
| 7/15/2022 |
July 15, 2022 Approval Letter - Alinity s Anti-HCV II assay |
| 7/15/2022 |
July 8, 2022 Summary of Safety and Effectiveness Data - Alinity m HIV-1 |
| 7/13/2022 |
July 8, 2022 Approval Order – Alinity m HIV-1 |
| 7/11/2021 |
BK210661 - RegenKit-Wound Gel-2 |
| 7/8/2022 |
July 8, 2022 Approval Letter - COMIRNATY |
| 7/7/2022 |
May 26, 2022 Clinical Memo - KYMRIAH |
| 7/7/2022 |
April 1, 2022 Statistical Review - KYMRIAH |
| 7/6/2022 |
June 30, 2022 Approval Letter (Replacement) - IMLYGIC |
| 7/6/2022 |
June 14, 2022 Approval Letter - IMLYGIC |
| 7/6/2022 |
Influenza Vaccine for the 2022-2023 Season |
| 7/6/2022 |
Seasonal Information for Influenza Virus Vaccine |
| 7/5/2022 |
July 1, 2022 Approval Letter - FLUARIX QUADRIVALENT |
| 7/5/2022 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year |
| 7/5/2022 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals |
| 7/5/2022 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year |
| 7/5/2022 |
July 1, 2022 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent |
| 7/5/2022 |
July 1, 2022 Approval Letter - Afluria and Afluria Quadrivalent |
| 7/5/2022 |
July 1, 2022 Approval Letter - Flublok Quadrivalent |
| 7/5/2022 |
July 1, 2022 Approval Letter - Flucelvax Quadrivalent |
| 7/5/2022 |
July 1, 2022 Approval Letter - FLUAD QUADRIVALENT |
| 7/5/2022 |
July 1, 2022 Approval Letter - FluLaval Quadrivalent |
| 7/1/2022 |
Complete List of Licensed Products and Establishments |
| 7/1/2022 |
Complete List of Substantially Equivalent 510(k) Device Applications |
| 7/1/2022 |
Complete List of Currently Approved Premarket Approvals (PMAs) |
| 7/1/2022 |
Complete List of Currently Approved NDA and ANDA Application Submissions |
| 7/1/2022 |
June 24, 2022 Clinical Review Memorandum - BREYANZI |
| 7/1/2022 |
June 24, 2022 Statistical Reviewer - BREYANZI |
| 7/1/2022 |
Clinical Pharmacology Review - BREYANZI |
| 7/1/2022 |
Memorandum Re: Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation |
| 6/30/2022 |
BK220724 - ORTHO Optix Reader |
| 6/30/2022 |
Update: COVID-19 Vaccine Booster Composition |
| 6/29/2022 |
June 3, 2022 Summary Basis for Regulatory Action - PRIORIX |
| 6/28/2022 |
Biological Product Deviation Reports Annual Summaries |
| 6/27/2022 |
June 24, 2022 Approval Letter - ORTHO Sera |
| 6/27/2022 |
June 24, 2022 Approval Letter - BREYANZI |
| 6/23/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer |
| 6/23/2022 |
June 21, 2022 Approval Letter - VISTASEAL |
| 6/23/2022 |
Interactions with Office of Tissues and Advanced Therapies |
| 6/22/2022 |
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022 |
| 6/22/2022 |
Federal Register Notice: Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program |
| 6/21/2022 |
2022 Biological License Application Approvals |
| 6/21/2022 |
2022 Biological License Application Supplement Noteworthy Approvals |
| 6/21/2022 |
2022 Biological Device Application Approvals |
| 6/21/2022 |
June 17, 2022 Approval Letter - VAXNEUVANCE |
| 6/17/2022 |
June 16, 2022 Approval Letter - MenQuadfi |
| 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 |
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 |
