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  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

Items related to biologics will be added to the top of the list as they are posted on the site.

11/17/2021 October 1, 2021 Clinical Review and Evaluation - TECARTUS
11/17/2021 Pharmacology/Toxicology Review - TECARTUS
11/17/2021 Statistical Review - TECARTUS
11/17/2021 Clinical Review - CUTAQUIG
11/17/2021 Statistical Review - CUTAQUIG
11/17/2021 CBER-Regulated Products: Current Shortages
11/17/2021 2021 Biological License Application Approvals
11/17/2021 2021 Biological Device Application Approvals
11/17/2021 2021 Biological License Application Supplement Noteworthy Approvals
11/16/2021 eSubmitter Application History
11/12/2021 CBER-Regulated Products: Resolved Shortages
11/10/2021 November 5, 2021 Untitled Letter - NYC Regenerative Medicine, Inc. dba Colts Neck Stem Cells and Regenerative Medicine
11/10/2021 November 8, 2021 Summary Basis for Regulatory Action - Comirnaty
11/8/2021 eSubmitter Application History
11/8/2021 CBER Vacancy: Principal Investigator - Pathogen Reduction of Whole Blood: Hematology and Coagulation Biology
11/8/2021 CBER Vacancy: Principal Investigator – Pathogen Reduction of Whole Blood: Microbiology and Infectious Diseases
11/5/2021 CBER Vacancy: Staff Fellow - Biologist/Microbiologist
11/4/2021 Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates
11/3/2021 Influenza Vaccine for the 2021-2022 Season
11/3/2021 Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry
11/2/2021 October 27, 2021 Approval Letter - KOVALTRY
11/2/2021 Complete List of Licensed Products and Establishments
11/2/2021 Complete List of Substantially Equivalent 510(k) Device Applications
11/2/2021 Complete List of Currently Approved Premarket Approvals (PMAs)
11/2/2021 Complete List of Currently Approved NDA and ANDA Application Submissions
11/2/2021 BK210621 - rControl RBC and PLT
11/1/2021 October 29, 2021 Approval Letter - AUDENZ
10/29/2021 October 8, 2021 Summary Basis for Regulatory Action - RETHYMIC
10/29/2021 October 27, 2021 Untitled Letter - Riverside Biologics
10/28/2021 October 27, 2021 Approval Letter - PNEUMOVAX 23
10/28/2021 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
10/28/2021 October 27, 2021 Approval Letter - MenQuadfi
10/28/2021 Influenza Vaccine for the 2021-2022 Season
10/27/2021 October 22, 2021 Approval Letter - CUTAQUIG
10/26/2021 October 22, 2021 Approval Letter - ZOLGENSMA
10/25/2021 2021 Biological License Application Approvals
10/25/2021 2021 Biological Device Application Approvals
10/22/2021 Clinical Review (125408/351) - Flucelvax Quadrivalent
10/22/2021 Statistical Review (125408/351) - Flucelvax Quadrivalent
10/22/2021 PREA Non-Compliance Letters
10/21/2021 Staff Fellow – Bioinformatics Reviewer
10/21/2021 Influenza Vaccine for the 2021-2022 Season
10/19/2021 PREA Non-Compliance Letters

 



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