- Guidance 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
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Guidance 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 - Pathogen Reduction Technologies for Blood Safety; Public Workshop
Updated: 2/8/2019 - Quantitation of AAV-Based Gene Therapy Products
Updated: 2/8/2019 - CBER Vacancy: Director, Division of Epidemiology - Title 38(F) Supervisory Physician (GP-0602-15)
Posted: 2/7/2019 Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS) (PDF - 1.5MB)
Updated: 2/7/2019February 4, 2019 Approval Letter - Fluzone Quadrivalent -Sourthern Hemisphere (PDF - 33KB)
Posted: 2/5/2019- Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Posted: 2/5/2019; Updated as of 2/1/2019 - Complete List of Licensed Products and Establishments
Posted: 2/4/2019; Updated as of 1/31/2019 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 31KB)
Posted: 2/4/2019; Updated as of 1/31/2019Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB)
Posted: 2/4/2019; Updated as of 1/31/2019Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 697KB)
Posted: 2/4/2019; Updated as of 1/31/2019- Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot L67530 through January 31, 2020
Posted: 2/1/2019 - BK180306 - MacoPress Smart Smarter and DMS Plus
Posted: 1/31/2019 Fast Track Designation Request Performance
Updated: 1/30/2019- Malaria gene activity findings could form basis of improved test for monitoring disease spread
Posted: 1/30/2019 - BK180258 - Vista Information System
Posted: 1/30/2019 - BK180280 - DG Gel Essential Control
Posted: 1/29/2019 - eSubmitter Application History
Updated: 1/29/2019
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