# Whats New Vaccines Blood Biologics RSS Feed

- Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023 This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.
- FDA Roundup: January 30, 2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- Recently Issued Guidance Documents This page lists Recently Issued CBER and Cross-Center Guidance Documents.
- Clinical Guidances This page lists Clinical Guidance documents.
- What’s New for Biologics Latest news from the Center for Biologics Evaluation and Research
- Drugs@FDA Data Files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
- Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023 This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.
- Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities
- CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 CDER Scientific Reviews Supporting EUA for Therapeutic Products
- Human Gene Therapy Products Incorporating Human Genome Editing This is the guidance Human Gene Therapy Products Incorporating Human Genome Editing
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products This is the guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
- Biologics PREA Reviews and Labeling Changes PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under
- Charter of the Vaccines and Related Biological Products Advisory Committee This is the Charter of the Vaccines and Related Biological Products Advisory Committee.
- GAMMAGARD LIQUID Product approval information is indicated for:•	Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.•	Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
- Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
- Afluria, Afluria Southern Hemisphere For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
- OTP Events, Meetings, and Workshops Office of Therapeutic Products Events, Meetings, and Workshops
- Biologics Guidances This page displays links to Biologics Guidance documents.
- Guidance Agenda:  Guidance Documents CBER is Planning to Publish During Calendar Year 2024 This is the list of guidance topics CBER is considering for development during Calendar Year 2024
- Cellular & Gene Therapy Guidances This page contains a listing of cellular and gene therapy guidances.