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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.

02/05/2026Computer Software Assurance for Production and Quality Management System Software; Guidance for Industry and Food and Drug Administration Staff
02/05/2026BK251168- Precise Cell Concentration System
02/04/2026Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff
01/21/2026Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval; Draft Guidance for Industry
01/15/2026SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
01/15/2026SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications
01/14/2026December 16, 2025 Summary Basis for Regulatory Action - FESILTY
01/14/2026Guiding Principles of Good AI Practice in Drug Development
01/12/2026Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry
01/11/2026Flexible Requirements for Cell and Gene Therapies to Advance Innovation
01/09/2026

2026 Safety and Availability Communications

01/09/2026Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026
01/09/2026SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment
01/08/2026BK251248- PRiSM PRP
01/08/2026BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
01/08/2026BK251245- Procleix® WNV/ Babesia Quality Control
01/08/2026Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff
01/06/2026BK251207- Multichem ID-HIV p24
01/05/2026BK251197- “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200)
12/31/2025December 29, 2025 Approval Letter - ALTUVIIIO


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