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        News & Events (Biologics)

What’s New for Biologics Home
          Vaccines, Blood & Biologics
          News & Events (Biologics)
          What’s New for BiologicsNews & Events (Biologics) What’s New for Biologics
  			Latest News from the Center for Biologics Evaluation and Research at FDA
	
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1/30/2024
			Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry1/29/2024
			January 26, 2024 Approval Letter - GAMMAGARD LIQUID1/29/2024
			Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 20241/29/2024
			January 26, 2024 Approval Letter - Afluria Trivalent and Afluria Quadrivalent1/29/2024
			Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry1/29/2024
			Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry1/29/2024
			CBER Cures Vacancy Announcement - Mathematical Statistician, AD-1529-Band D, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB)1/26/2024
			Formal Meetings for CBER-Regulated Products1/26/2024
			SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products1/25/2024
			Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
			Data as of December 31, 20231/25/2024
			CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
			Data as of December 31, 20231/25/2024
			CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
			Data as of December 31, 20231/25/2024
			CBER Vacancy: Staff Fellow - Researcher-Reviewer1/24/2024
			CBER Title 21 Vacancy Announcement - Deputy Office Director, Band F, Office of Blood Research and Review (OBRR), Immediate Office (IO)1/24/2024
			January 23, 2024 Safety Labeling Change Notification Letter - TECARTUS (brexucabtagene autoleucel)1/23/2024
			January 16, 2024 Untitled Letter - Vitacell Biologics, LLC1/22/2024
			January 19, 2024 Safety Labeling Change Notification Letter - ABECMA (idecabtagene vicleucel)1/22/2024
			January 19, 2024 Safety Labeling Change Notification Letter - BREYANZI (lisocabtagene maraleucel)1/22/2024
			January 19, 2024 Safety Labeling Change Notification Letter - CARVYKTI (ciltacabtagene autoleucel)1/22/2024
			January 19, 2024 Safety Labeling Change Notification Letter - KYMRIAH (tisagenlecleucel)1/22/2024
			January 19, 2024 Safety Labeling Change Notification Letter - YESCARTA (axicabtagene ciloleucel)1/22/2024
			CBER Title 21 Vacancy Announcement – Physician, AD-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation General Medicine (DCEGM), General Medicine Branch (GMB)1/19/2024
			CBER 2024 Orphan Approvals1/19/2024
			December 22, 2023 Summary of the Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device1/18/2024
			CBER Title 21 Vacancy Announcement – Associate Director of Labeling, AD-Band D, Office of Vaccines Research and Review (OVRR), Division of Clinical and Toxicology Review (DCTR)1/18/2024
			CBER Cures Vacancy Announcement - Data Scientist, AD-0301-Band C, Office of Regulatory Operations (ORO), Division of Informatics (DI)1/17/2024
			December 22, 2023 Approval Letter - RECELL Autologous Cell Harvesting Device1/16/2024
			January 16, 2024 Approval Letter - CASGEVY (STN 125785)1/16/2024
			January 12, 2024 Approval Letter - HYQVIA1/16/2024
			CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)1/12/2024
			Common Ingredients in FDA-Approved Vaccines1/11/2024
			January 10, 2024 Approval Letter - ELEVIDYS1/11/2024
			Clinical Investigator Status (Biologics)
			Updated through 12/31/20231/11/2024
			Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff1/10/2024
			eSubmitter Application - Version 3.75.00 - Released 12/08/20231/9/2024
			SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)1/9/2024
			Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer1/5/2024
			December 8, 2023 Summary Basis for Regulatory Action - LYFGENIA1/5/2024
			January 4, 2024 Approval Letter - RECOTHROM1/4/2024
			December 15, 2023 Summary Basis for Regulatory Action - ALYGLO1/3/2024
			December 8, 2023 Summary Basis for Regulatory Action - CASGEVY1/2/2024
			Complete List of Licensed Products and Establishments
			Update1/2/2024
			Complete List of Substantially Equivalent 510(k) Device Applications
			Update1/2/2024
			Complete List of Currently Approved Premarket Approvals (PMAs)
			Update1/2/2024
			Complete List of Currently Approved NDA and ANDA Application Submissions
			Update

                                                                                  Content current as of:
      01/30/2024
                  
                   
Regulated Product(s)
		 BiologicsWhat’s New for Biologics
 
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