What's New at CBER

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What's New Today

The following links have been updated recently:

Posted: 10/04/2023

• October 3, 2023 Approval Letter - RabAvert
• BR220665 - HEMANEXT ONE

Workshops, Meetings & Conferences

November Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards November 7, 2023

October 2023 Warrior Families Webinar October 5, 2023 Vaccines and Related Biological Products Advisory Committee Meeting October 5, 2023 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting October 31, 2023

2024

Workshops, Meetings & Conferences

Public Workshop: Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop

February 22, 2024

Update

Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023

Request for Comments

Draft Guidance on Manufacturing Changes

New draft guidance on manufacturing changes and comparability for human cellular and #GeneTherapy products. Listen to this recorded webinar for a high-level overview and submit comments to the docket by November 13, 2023: