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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.

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
10/15/2021 October 14, 2021 Approval Letter - FLUCELVAX QUADRIVALENT
10/14/2021 Influenza Vaccine for the 2021-2022 Season
10/13/2021 CBER Vacancy: Principal Investigator – Microbial Pathogenesis
10/12/2021 CBER Vacancy: Staff Fellow - Pharmacology/Toxicology Reviewer
10/12/2021 BK210620 - BloodRelay 1.1.0
10/12/2021 October 8, 2021 Approval Letter - OBIZUR
10/8/2021 October 8, 2021 Approval Letter - RETHYMIC
10/8/2021 CBER-Regulated Products: Current Shortages
10/6/2021 Influenza Vaccine for the 2021-2022 Season
10/6/2021 October 5, 2021 Approval Letter - HESPAN (6% Hetastarch in 0.9% Sodium Chloride injection)
10/6/2021 October 5, 2021 Approval Letter - HEXTEND (6% Hydroxyethyl Starch in Lactated Electrolyte Injection)
10/5/2021 Regenerative Medicine Advanced Therapy Designation
10/5/2021 Preguntas y respuestas sobre Comirnaty (Vacuna de ARNm contra el COVID-19)
10/4/2021 October 1, 2021 Approval Letter - TECARTUS
10/1/2021 Q&A for Comirnaty (COVID-19 Vaccine mRNA)
10/1/2021 Complete List of Licensed Products and Establishments
10/1/2021 Complete List of Substantially Equivalent 510(k) Device Applications
10/1/2021 Complete List of Currently Approved Premarket Approvals (PMAs)
10/1/2021 Complete List of Currently Approved NDA and ANDA Application Submissions
10/1/2021 September 29, 2021 Approval Letter - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445/47
10/1/2021 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
10/1/2021 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes
10/1/2021 Biological Product Deviation Reporting - Blood Product Codes
9/30/2021 Influenza Vaccine for the 2021-2022 Season
9/29/2021 CBER Advanced Technologies Program Extramural Research Funding
9/29/2021 CBER Advanced Technologies Program
9/29/2021 Expiration Date Extension for Dextran 40 (10% LMD in 5% Dextrose Injection) Lot 09141JT through May 1, 2022 and 12090JT through August 1, 2022
9/29/2021 Expiration Date Extension for Dextran 40 (10% LMD in 0.9% Sodium Chloride Injection) Lot 07011JT through June 1, 2022
9/29/2021 Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry
9/29/2021 Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry

 



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