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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.

12/4/2023 December 1, 2023 Approval Letter - Wilate
12/01/2023 December 1, 2023 Approval Letter - ODACTRA
11/30/2023 November 9, 2023 Summary Basis for Regulatory Action - ADZYNMA
11/30/2023 November 29, 2023 Approval Letter - Fluzone
11/29/2023 COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
11/29/2023 Warrior Families: Advancing Regenerative Medicine Through Science Webinar Transcript
11/29/2023 Warrior Families: Advancing Regenerative Medicine Through Science Presentation Slides
11/28/2023 Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
11/28/2023 BK231004- Blood Product Questionnaire Module
11/28/2023 FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
11/27/2023 Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
(Updated November 27, 2023)
11/27/2023 November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA
11/27/2023 SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/21/2023 CBER CURES Vacancy Announcement – Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD)
Updated closing date
11/20/2023 Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
11/15/2023 CBER 2023 Orphan Approvals (new BLAs) - Updated
11/14/2023 eSubmitter Application History
11/13/2023 November 9, 2023 Approval Letter - PALFORZIA
11/13/2023 CBER Cures Vacancy Announcement - Biological Regulatory Specialist, Band C, CBER/ORO/IOD/CMCT
11/09/2023 November 9, 2023 Approval Letter - ADZYNMA
11/09/2023 November 9, 2023 Approval Letter - IXCHIQ
11/7/2023 BK230840- Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV
11/7/2023 BK230986 - ePROGESA v5.0.3
11/6/2023 Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
11/3/2023 WCBP Symposium 2024
Event date: January 23 - 25, 2024
11/3/2023 CBER Staff Fellow - Product/Chemistry, Manufacturing and Controls (CMC) Reviewer
11/2/2023 Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies
11/1/2023 Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
11/1/2023 Complete List of Licensed Products and Establishments
Updated as of 10/31/2023
11/1/2023 Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 10/31/2023
11/1/2023 Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 10/31/2023
11/1/2023 Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 10/31/2023
11/1/2023 CBER Cures Vacancy Announcement – Division Director, AD-Band F, Office of Therapeutic Products (OTP), Office of Cellular Therapy & Human Tissue CMC (OCTHT), Division of Human Tissue (DHT)
10/30/2023 October 27, 2023 Approval Letter - HAVRIX
10/30/2023 October 27, 2023 Approval Letter - ENGERIX-B
10/27/2023 October 27, 2023 Approval Letter - BOOSTRIX
10/27/2023 October 27, 2023 Approval Letter - KINRIX
10/27/2023 October 27, 2023 Approval Letter - INFANRIX
10/26/2023 CBER Cures Vacancy Announcement - Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD)
10/26/2023 October 16, 2023 Summary Basis for Regulatory Action - Elecsys HTLV-I/II
10/25/2023 Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Draft Guidance for Industry
10/24/2023 Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
10/23/2023 Important Information About Directed Blood Donations that are Not Medically Indicated
10/20/2023 October 20, 2023 Approval Letter - PENBRAYA
10/20/2023 2023 Biological License Application Approvals
Updated as of 9/30/2023
10/20/2023 2023 Biological License Application Supplement Noteworthy Approvals
Updated as of 9/30/2023
10/20/2023 2023 Biological Device Application Approvals
Updated as of 9/30/2023
10/19/2023 Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
10/19/2023 Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
10/18/2023 Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry
10/18/2023 October 17, 2023 Approval Letter - ZOLGENSMA
10/18/2023 Transcript for the FDA CBER OTP Listening Meeting: Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
10/17/2023 October 17, 2023 Approval Letter - COMIRNATY
10/17/2023 October 17, 2023 Approval Letter - Elecsys HTLV-I/II
10/17/2023 Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry


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