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  1. News & Events (Biologics)

What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

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

2/22/2023 February 22, 2023 Approval Letter - ALTUVIIIO
2/22/2023 February 22, 2023 Approval Replacement Letter - ALTUVIIIO
2/22/2023 BK220790 - Blood Bank Control System, Version 6.0
2/17/2023 Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products
Updated with transcript.
2/17/2023 Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
2/17/2023 Joint US FDA – Health Canada ICH Public Meeting
2/17/2023 2023 Biological License Application Approvals
2/17/2023 2023 Biological Device Application Approvals
2/17/2023 2023 Biological License Application Supplement Noteworthy Approvals
2/17/2023 FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop
2/16/2023 February 16, 2023 Approval Letter - ZOLGENSMA
2/16/2023 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
2/15/2023 February 10, 2023 Approval Letter - IMLYGIC
2/14/2023 February 13, 2023 Approval Letter - Fluzone Quadrivalent Southern Hemisphere and  Fluzone High-Dose Quadrivalent Southern Hemisphere
2/13/2023 Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
2/10/2023 Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry
2/9/2023 User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
2/9/2023 eSubmitter Application History
2/9/2023 Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement
2/6/2023 Extension of the Expiration Date for MICRhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] Lot MG21O04 from 24 months to 36 months (28 JAN 2023, to 28 JAN 2024)
2/3/2023 January 20,2023 Clinical Review Memo - ODACTRA
2/3/2023 Statistical Review - ODACTRA
2/2/2023 CBER Vacancy: Staff Fellow/Visiting Associate - Biologist
2/1/2023 Complete List of Licensed Products and Establishments
2/1/2023 Complete List of Substantially Equivalent 510(k) Device Applications
2/1/2023 Complete List of Currently Approved Premarket Approvals (PMAs)
2/1/2023 Complete List of Currently Approved NDA and ANDA Application Submissions
2/1/2023 Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry
2/1/2023 Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement
1/30/2023 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023
1/27/2023 January 20, 2023 Approval Letter - ODACTRA
1/27/2023 Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry
1/25/2023 January 25, 2023 Approval Letter - DENGVAXIA
1/23/2023 CBER Vacancy: Product/Chemistry, Manufacturing and Controls (CMC) Reviewer


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