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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.

1/20/2023 January 9, 2023 Statistical Review - ADACEL
1/20/2023 January 9, 2023 Clinical Review - ADACEL
1/17/2023 BK220775 - Procedure Tray-Lipoaspirate fat harvest and injection kit
1/13/2023 CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older
1/13/2023 Clinical Investigator Status (Biologics)
1/13/2023 January 12, 2023 Approval Letter - FluMist
1/12/2023 Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
1/12/2023 December 16, 2022 Summary Basis for Regulatory Action - ADSTILADRIN
1/11/2023 eSubmitter Application History
1/11/2023 Tissue Reference Group - Updated
1/11/2023 FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - Updated with transcripts.
1/10/2023 Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
1/10/2023 CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
1/10/2023 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
1/10/2023 January 9, 2023 Approval Letter - ADACEL
1/9/2023 OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases
1/6/2023 CBER Vacancy: Health Scientist (Digital Health Specialist)
1/4/2023 Format and Content of a REMS Document; Guidance for Industry
1/3/2023 Complete List of Licensed Products and Establishments
1/3/2023 Complete List of Substantially Equivalent 510(k) Device Applications
1/3/2023 Complete List of Currently Approved Premarket Approvals (PMAs)
1/3/2023 Complete List of Currently Approved NDA and ANDA Application Submissions
1/3/2023 BK220788 - Aurora Xi Plasmapheresis System
12/27/2022 BK220767 - Lipocube Nano, Liopcube Hybrid I, Lipocube Hybrid II, Centrifuge Container
12/23/2022 Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated with video recordings.
12/22/2022 BK220785 - Transfer Packs
12/22/2022 December 20, 2022 Approval Letter - ARALAST NP
12/22/2022 Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
12/20/2022 2022 Biological License Application Approvals
12/20/2022 2022 Biological License Application Supplement Noteworthy Approvals
12/20/2022 2022 Biological Device Application Approvals
12/20/2022 November 22, 2022 Summary Basis for Regulatory Action - HEMGENIX
12/20/2022 Voluntary Lot Withdrawals of Allergenic Extract – Peanut (Arachis hypogaea)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
12/19/2022 CBER Vacancy: Principal Investigator - Interdisciplinary Scientist
12/19/2022 December 16, 2022 Approval Letter - TENIVAC
12/19/2022 Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement


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