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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.

2/6/2023 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2/1/2023 Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry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Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry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
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Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry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
1/4/2023 Format and Content of a REMS Document; Guidance for Industry


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