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.

7/1/2022	Complete List of Licensed Products and Establishments
7/1/2022	Complete List of Substantially Equivalent 510(k) Device Applications
7/1/2022	Complete List of Currently Approved Premarket Approvals (PMAs)
7/1/2022	Complete List of Currently Approved NDA and ANDA Application Submissions
7/1/2022	June 24, 2022 Clinical Review Memorandum - BREYANZI
7/1/2022	June 24, 2022 Statistical Reviewer - BREYANZI
7/1/2022	Clinical Pharmacology Review - BREYANZI
7/1/2022	Memorandum Re: Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation
6/30/2022	BK220724 - ORTHO Optix Reader
6/30/2022	Update: COVID-19 Vaccine Booster Composition
6/29/2022	June 3, 2022 Summary Basis for Regulatory Action - PRIORIX
6/28/2022	Biological Product Deviation Reports Annual Summaries
6/27/2022	June 24, 2022 Approval Letter - ORTHO Sera
6/27/2022	June 24, 2022 Approval Letter - BREYANZI
6/23/2022	CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer
6/23/2022	June 21, 2022 Approval Letter - VISTASEAL
6/23/2022	Interactions with Office of Tissues and Advanced Therapies
6/22/2022	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022
6/22/2022	Federal Register Notice: Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program
6/21/2022	2022 Biological License Application Approvals
6/21/2022	2022 Biological License Application Supplement Noteworthy Approvals
6/21/2022	2022 Biological Device Application Approvals
6/21/2022	June 17, 2022 Approval Letter - VAXNEUVANCE
6/17/2022	June 16, 2022 Approval Letter - MenQuadfi
6/15/2022	June 15, 2022 Approval Letter - Procleix Ultrio Elite Assay
6/15/2022	Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry
6/13/2022	Expiration Date Extension for 6 ASCENIV [Immune Globulin Intravenous, Human-slra, 10% Liquid] Lots manufactured in 2019 - 2020
6/10/2022	eSubmitter Download and Installation
6/10/2022	BK210653 - ORTHO Daily QC Simulated Whole Blood Quality Control Kit
6/9/2022	Coronavirus (COVID-19) \| CBER-Regulated Biologics
6/9/2022	Letter to Sponsors, Applicants and Regulated Entities on COVID-19
6/9/2022	eSubmitter Application History
6/9/2022	June 8, 2022 Approval Letter – LUXTURNA
6/8/2022	May17, 2021 Summary Basis for Regulatory Action - Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal
6/8/2022	CBER-Regulated Products: Resolved Shortages
6/7/2022	June 3, 2022 Approval Letter – Anti-Human Globulin and Blood Grouping Reagent (BL 103461/5118, et.al)
6/6/2022	June 2, 2022 Approval Letter - Blood Grouping Reagents, Anti-Ds ((Monoclonal) (IgM), (Monoclonal) (IgM Blend) and (Monoclonal Blend))
6/6/2022	May 17, 2022 Summary Basis for Regulatory Action - DG Gel 8 Direct Coombs
6/3/2022	June 3, 2022 Approval Letter – PRIORIX
6/3/2022	June 2, 2022 Approval Letter - IPOL