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  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

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

4/12/2021 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021
4/8/2021 Annual Summary for Fiscal Year 2020
4/7/2021 eSubmitter Application History
4/6/2021 Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates
4/6/2021 CBER Vacancy: Staff Fellow/Visiting Associate: Cell Biology
4/5/2021 Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
4/5/2021 CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
4/5/2021 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
4/5/2021 March 23, 2021 Untitled Letter - Curex, Inc.
4/5/2021 CBER-Regulated Products: Resolved Shortages
4/2/2021 Complete List of Licensed Products and Establishments
4/2/2021 Complete List of Substantially Equivalent 510(k) Device Applications
4/2/2021 Complete List of Currently Approved Premarket Approvals (PMAs)
4/2/2021 Complete List of Currently Approved NDA and ANDA Application Submissions
3/31/2021 TRG Rapid Inquiry Program (TRIP)
3/30/2021 March 29, 2021 Untitled Letter - Neil P. Sheth, MD
3/27/2021 March 26, 2021 Approval Letter - ABECMA
3/25/2021 March 3, 2021 Approval Letter - IXINITY
3/25/2021 March 24, 2021 Approval Letter - SHINGRIX
3/24/2021 FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix
3/24/2021 March 22, 2021 Untitled Letter - Michael L. Levin, MD
3/22/2021 2021 Biological License Application Approvals
3/22/2021 2021 Biological License Application Supplement Noteworthy Approvals
3/22/2021 2021 Biological Device Application Approvals
3/22/2021 eSubmitter Application History
3/19/2021 CBER 2021-2025 Strategic Plan
3/16/2021 March 16, 2021 Approval Letter - ZOLGENSMA
3/12/2021 March 10, 2021 Untitled Letter - Reno Integrative Medical Center
3/12/2021 Clinical Review (STN: 125408/329) - Flucelvax Quadrivalent
3/12/2021 Statistical Review (STN: 125408/329) - Flucelvax Quadrivalent
3/12/2021 BK200549 - ORTHO Optix Reader
3/11/2021 March 10, 2021 Approval Letter - Anti-Human Globulin (BL 1034615114) and Blood Grouping Reagent (103756/5095 et al.)
3/11/2021 March 10, 2021 Approval Letter - 0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS
3/9/2021 Tissue Establishment Registration
3/9/2021 eSubmitter Application History

 



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