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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.

12/7/2022 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium - Updated
12/7/2022 Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
12/6/2022 CBER Vacancy: Staff Fellow/Visiting Associate – Biologist
12/5/2022 Clinical Review Memo of Labeling Supplement – SEVENFACT
12/01/2022 FDA Clinical Investigator Training Course (CITC) 2022
12/01/2022 BR220737 De Novo Classification Order
11/30/2022 November 30, 2022 Approval Letter - REBYOTA
11/28/2022 November 23, 2022 Approval Letter - KINRIX
11/28/2022 Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Guidance for Industry
11/25/2022 November 23, 2022 Approval Letter - INFANRIX
11/25/2022 November 23, 2022 Approval Letter - BOOSTRIX
11/25/2022 Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products - Updated
11/25/2022 FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - Updated
11/23/2022 November 22, 2022 Approval Letter - SEVENFACT
11/23/2022 Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products
11/22/2022 November 22, 2022 Approval Letter - HEMGENIX
11/18/2022 November 17, 2022 Approval Letter - IXINITY
11/17/2022 OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls Transcript
11/16/2022 Principal Investigator - Interdisciplinary Scientist
11/16/2022 2022 Biological License Application Supplement Noteworthy Approvals
11/16/2022 2022 Biological Device Application Approvals
11/14/2022 SOPP 8405.1: Procedures for Resubmissions to an Application or Supplement
11/14/2022 SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Products Licenses
11/10/2022 Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
11/7/2022 November 4, 2022 Approval Letter - ROTARIX
11/7/2022 November 3, 2022 Approval Letter - VARIVAX (refrigerated and frozen formulations)
11/7/2022 CBER-Regulated Products: Current Shortages
11/7/2022 Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry


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