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  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

 

Items related to biologics will be added to the top of the list as they are posted on the site.

 

4/6/2020 Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli
4/6/2020 eSubmitter Application History
4/3/2020 Investigational COVID-19 Convalescent Plasma - Emergency INDs
4/3/2020 March 30, 2020 Summary Basis for Regulatory Action - DG Gel 8 ABO/Rh (2D)
4/3/2020 Regenerative Medicine Advanced Therapy Designation
4/3/2020 April 1, 2020 Untitled Letter - Dynamic Stem Cell Therapy
4/2/2020 Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry
4/2/2020 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
4/2/2020 Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
4/2/2020 Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
4/2/2020 Expiration Date Extension for Anavip [Crotalidae Immune F(ab’)2 (Equine)]: Lot B-8G-33 through July 31, 2021; Lot B-9B-33 through February 28, 2022; and Lot B-9E-35 through June 30, 2022
4/2/2020 Complete List of Licensed Products and Establishments
4/2/2020 Complete List of Substantially Equivalent 510(k) Device Applications
4/2/2020 Complete List of Currently Approved Premarket Approvals (PMAs)
4/2/2020 Complete List of Currently Approved NDA and ANDA Application Submissions
4/1/2020 Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic
4/1/2020 CBER Vacancy: Staff Fellow – Bioinformatics (Individualized Cell and Gene Therapies)
4/1/2020 April 1, 2020 Approval Letter -SEVENFACT
4/1/2020 April 1, 2020 Approval Letter - Fluzone Quadrivalent
4/1/2020 March 30 Approval Letter - DG Gel 8 ABO/Rh (2D)
3/27/2020 Letter to Sponsors, Applicants and Regulated Entities on COVID-19
3/27/2020 Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines
3/26/2020 Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions
3/26/2020 2020 Biological License Application Supplement Noteworthy Approvals
3/26/2020 2020 Biological Device Application Approvals
3/26/2020 TRG Rapid Inquiry Program (TRIP)
3/24/2020 March 23, 2020 Approval Letter - VAXELIS
3/24/2020 Investigational COVID-19 Convalescent Plasma - Emergency INDs
3/23/2020 March 20, 2020 Approval Letter - Typhim Vi
3/23/2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
3/20/2020 March 20, 2020 Approval Letter - Fluarix Quadrivalent
3/19/2020 Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
3/18/2020 Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays
3/18/2020 March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.
3/18/2020 March 13, 2020 Approval Letter - ALBAclone STN#125309-64
3/16/2020 eSubmitter Application History
3/16/2020 Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement
3/13/2020 Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/13/2020 BK190430 - Anti-D Donor Management and Inventory System (ADIMS)
3/13/2020 BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports
3/13/2020 CBER-Regulated Products: Resolved Shortages
3/12/2020 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
3/12/2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/12/2020 Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry
3/11/2020 Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
3/11/2020 BK190434 - ORTHO CONNECT 3.0
3/11/2020 Regulatory Submissions - Electronic and Paper