What’s New for Biologics | FDA

Items related to biologics will be added to the top of the list as they are posted on the site.01/12/2026Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry01/11/2026Flexible Requirements for Cell and Gene Therapies to Advance Innovation01/09/20262026 Safety and Availability CommunicationsJanuary 9, 2026 Safety Labeling Notification Letter - FluzoneJanuary 9, 2026 Safety Labeling Notification Letter - FlumistJanuary 9, 2026 Safety Labeling Notification Letter - FluarixJanuary 9, 2026 Safety Labeling Notification Letter - FlulavalJanuary 9, 2026 Safety Labeling Notification Letter - AfluriaJanuary 9, 2026 Safety Labeling Notification Letter - Flucelvax01/09/2026Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 202601/09/2026SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment01/08/2026BK251248- PRiSM PRP01/08/2026BK251286- 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 systems01/08/2026BK251245- Procleix® WNV/ Babesia Quality Control01/08/2026Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff01/06/2026BK251207- Multichem ID-HIV p2401/05/2026BK251197- “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200)12/31/2025December 29, 2025 Approval Letter - ALTUVIIIO12/22/2025December 19, 2025 Approval Letter - RIASTAP12/22/2025Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff12/19/2025November 24, 2025 Summary Basis for Regulatory Action - ITVISMA12/19/2025December 19, 2025 Approval Letter - ABRYSVO12/19/2025December 9, 2025 Summary Basis for Regulatory Action - WASKYRA12/18/2025Update on the Safety of Andexxa12/17/2025December 16, 2025 Approval Letter - FESILTY12/17/2025December 17, 2025 Approval Letter - HIBERIX12/17/2025BK251265 - ORTHO® Elution Kit12/17/2025December 16, 2025 Approval Letter - Procleix Babesia Assay12/16/2025BK251285- Elecsys Syphilis12/16/2025Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry12/15/2025SOPP 8404: Refusal to File Procedures12/15/2025Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry12/15/2025Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Guidance for Industry12/15/2025SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products12/10/2025Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Guidance for Industry12/9/2025December 9, 2025 Approval Letter - WASKYRA