Recently Added
March 15, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant) (PDF - 42KB)
Posted: 3/19/2019March 15, 2019 Approval Letter - Anti-Fya (Murine Monoclonal) (Recombinant) (PDF - 40KB)
Posted: 3/19/2019- 2019 Biological License Application Approvals
Updated: 3/14/2019; New Entry for ESPEROCT - 2019 Biological Device Application Approvals
Updated 3/14/2019; New Entry for ALBAcyte lgG Sensitized Red Blood Cells II - BK180299 - Arthrex Thrombinator System
Posted: 3/11/2019 - BioCompute Objects: Tools for Communicating NGS Data and Analysis; Public Workshop
Posted: 3/7/2019 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB)
Posted: 3/4/2019; Updated as of 2/28/2019Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 33KB)
Posted: 3/4/2019; Updated as of 2/28/2019Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 701KB)
Posted: 3/4/2019; Updated as of 2/28/2019- Complete List of Licensed Products and Establishments
Posted: 3/4/2019; Updated as of 2/28/2019 February 28, 2019 Approval Letter - FluMist Quadrivalent (PDF - 33KB)
Posted: 3/1/2019- Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World
Posted: 2/28/2019 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (PDF - 102KB)
Updated: 2/28/2019- Vaccines for Children - A Guide for Parents and Caregivers
Updated: 2/22/2019 February 21, 2019 Approval Letter - ZOSTAVAX (PDF - 101KB)
Posted: 2/22/2019Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format; Guidance for Industry (PDF - 220KB)
Updated: 2/22/2019Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019 (PDF - 75KB)
Posted: 2/20/2019- 2019 Biological Device Application Approvals
Posted: 2/20/2019 - 2019 Biological License Application Supplement Noteworthy Approvals
Posted: 2/20/2019 - 2019 Biological License Application Approvals
Posted: 2/20/2019 February 19, 2019 Approval Letter - ESPEROCT (PDF - 75KB)
Posted: 2/19/2019- CBER Expanded Access Submission Receipt Reports
Updated: 2/19/2019; Reports for FY 2017 and FY 2018 added - Important Information about Young Donor Plasma Infusions for Profit
Posted: 2/19/2019 - CBER-Regulated Products: Current Shortages
Posted: 2/19/2019; Update on RECOMBIVAX HB - Pediatric/Adolescent formulation - Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (PDF - 219KB)
Updated: 2/15/2019 - Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry (PDF - 194KB)
Updated: 2/15/2019 - BK180286 - ALBAcyte IgG Sensitized Red Blood Cells II
Posted: 2/11/2019 - 22nd US-Japan Cellular and Gene Therapy Conference
Posted: 2/11/2019
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