What’s New for Biologics
- CBER FY 2017 Recall Postings
Posted: 10/4/2017 - BK170098: TSCD-II Sterile Tubing Welder with or without Trucise Total System
Posted: 10/3/2017 - BK170072: DXT Data Management System v3.0
Posted: 10/3/2017 - BK170071: IH-Com V5.0
Posted: 10/2/2017 - User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
Posted: 10/2/2017 - Biological Product Deviation Reporting - Blood Product Codes
Posted: 9/29/2017; Updated for October 1, 2017 - Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
Posted: 9/29/2017; Updated for October 1, 2017 - Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes
Posted: 9/29/2017; Updated for October 1, 2017 - CBER Vacancy: MEDICAL OFFICER (Multiple Positions)
Posted: 9/29/2017 - CBER Vacancy: POSTDOCTORAL STAFF FELLOW (BIOLOGIST/MICROBIOLOGIST/IMMUNOLOGIST), RG-0401/0403
Posted: 9/29/2017 Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World (PDF - 162KB)
Posted: 9/28/2017Important Information for Blood Establishments Regarding Zika Virus Transmission Risk in the World (PDF - 143KB)
Posted: 9/28/2017September 26, 2017 Approval Letter - Trumenba (PDF - 26KB)
Posted: 9/28/2017- Influenza Virus Vaccine for the 2017-2018 Season
Updated: 9/28/2017 Summary Basis for Regulatory Action - Prolastin-C (PDF - 295KB)
Posted: 9/27/2017Summary Basis for Regulatory Action - Anti-Human Globulin Anti-IgG (Rabbit) (PDF - 145KB)
Posted: 9/26/2017Summary Basis for Regulatory Action - ALBClone ANtiC3d (Murine Monoclonal) (PDF - 132KB)
Posted: 9/26/2017- 2016 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Updated: 9/26/2017 - 2017 Biological Device Application Approvals
Updated: 9/26/2017 - 2017 Biological License Application Supplement Noteworthy Approvals
Updated: 9/26/2017 - 2017 Biological License Application Approvals
Updated: 9/26/2017 September 21, 2017 Approval Letter - Prolastin-C (PDF - 38KB)
Updated: 9/26/2017- ALBAclone Anti-C3d (Murine Monoclonal)
Updated: 9/25/2017 - Anti-Human Globulin Anti-IgG (Rabbit)
Updated: 9/25/2017 September 14, 2017 SBRA-Privigen (PDF - 112KB)
Posted: 9/19/2017September 14, 2017 Approval Letter - Privigen (PDF - 42KB)
Posted: 9/18/2017- CBER-Regulated Products: Current Shortages
Updated: 9/18/2017 - Immune Globulin Potency in the 21st Century; Public Workshop
Posted: 9/18/2017 - Recommendations for Prophylaxis and Treatment of Hereditary Angioedema (HAE) Attacks
Posted: 9/15/2017 - Complete List of Licensed Products and Establishments
Posted: 9/13/2017; Updated as of 8/31/2017 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 21KB)
Posted: 9/13/2017; Updated as of 9/12/2017Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 21KB)
Posted: 9/13/2017; Updated as of 9/6/2017Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 284KB)
Posted: 9/13/2017; Updated as of 9/6/2017August 23, 2017 SBRA - KEDRAB (PDF - 236KB)
Posted: 9/12/2017- August 31, 2017 Clinical Review - Afluria Quadrivalent (PDF - 965KB)
Posted: 9/11/2017 - August 31, 2017 Statistical Review - Afluria Quadrivalent (PDF - 351KB)
Posted: 9/11/2017 August 29, 2017 Summary Basis for Regulatory Action - Afluria Quadrivalent (PDF - 142KB)
Posted:9/7/2017Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Guidance for Industry (PDF - 171KB)
Posted: 9/6/2017Statistical Review - T.R.U.E. TEST (PDF - 527KB)
Posted: 9/6/2017Clinical Review - T.R.U.E. TEST (PDF - 435KB)
Posted: 9/6/2017- New Recommendations to Increase the Dose of GamaSTAN S/D (Immune Globulin [Human]) When Used for Prophylaxis for Hepatitis A
Posted: 9/6/2017 August 31, 2017 Approval Letter - AFLURIA QUADRIVALENT (PDF - 34KB)
Posted: 9/5/2017
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