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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.

2/5/2020 Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry
2/4/2020 Complete List of Licensed Products and Establishments
2/4/2020 Complete List of Substantially Equivalent 510(k) Device Applications
2/4/2020 Complete List of Currently Approved Premarket Approvals (PMAs)
2/4/2020 Complete List of Currently Approved NDA and ANDA Application Submissions
2/4/2020 Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
2/3/2020 Facilitating End-to-End Development of Individualized Therapeutics
1/31/2020 January 31, 2020 Approval Letter - PALFORZIA
1/31/2020 January 31, 2020 Approval Letter - AUDENZ
1/31/2020 BK190429 - HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version)
1/30/2020 Clinical Review - Agriflu
1/30/2020 Statistical Review - Agriflu
1/30/2020 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry
1/29/2020 January 28, 2020 Approval Letter - Agriflu
1/28/2020 Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
1/28/2020 Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
1/28/2020 Human Gene Therapy for Retinal Disorders; Guidance for Industry
1/28/2020 Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
1/28/2020 Human Gene Therapy for Rare Diseases; Guidance for Industry
1/28/2020 Human Gene Therapy for Hemophilia; Guidance for Industry
1/28/2020 Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
1/24/2020 January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
1/24/2020 January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
1/23/2020 January 22, 2020 Approval Letter - DENGVAXIA
1/22/2020 BK190439 - MATCH IT! DNA (version 1.3)
1/22/2020 2019 Biological Device Application Approvals
1/22/2020 2019 Biological License Application Supplement Noteworthy Approvals
1/22/2020 2019 Biological License Application Approvals
1/17/2020 Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement
1/15/2020 December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
1/13/2020 CBER Vacancy: Physician, Division of Epidemiology (DE)
1/10/2020 Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Transcript
1/10/2020 January 8, 2020 Approval Letter - GRASTEK
1/9/2020 CBER-Regulated Products: Current Shortages
1/7/2020 CBER Vacancy: Senior Staff Fellow – Allergic Diseases


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