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.

12/6/2021	Complete List of Licensed Products and Establishments
12/6/2021	Complete List of Substantially Equivalent 510(k) Device Applications
12/6/2021	Complete List of Currently Approved Premarket Approvals (PMAs)
12/6/2021	Complete List of Currently Approved NDA and ANDA Application Submissions
12/6/2021	December 3, 2021 Approval Letter - HAVRI
12/2/2021	Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
12/01/2021	November 30, 2021 Approval Letter - PREHEVBRIO
11/29/2021	BK210574 - LIFECODES LSA Class II
11/29/2021	BK210573 - LIFECODES LSA Class I
11/29/2021	BK210572 - MATCH IT! Antibody
11/29/2021	November 17, 2021 Approval Letter - AUDENZ
11/24/2021	Principal Investigator – Viral Vaccines
11/23/2021	November 19, 2021 Approval Letter - Trumenba
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