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.

5/28/2021	Model Informed Drug Development Approaches for Immunogenicity Assessments
5/28/2021	Model Informed Drug Development Approaches for Immunogenicity Assessments Agenda
5/26/2021	CBER-Regulated Products: Current Shortages
5/25/2021	Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
5/21/2021	HCT/P Inspection Information
5/21/2021	Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement
5/20/2021	2021 Biological License Application Supplement Noteworthy Approvals
5/20/2021	2021 Biological Device Application Approvals
5/19/2021	May 17, 2021 Approval Letter - KEDRAB
5/18/2021	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
5/17/2021	BK210564 - ORTHO VISION Max Analyzer
5/17/2021	BK210557 - ORTHO VISION Analyzer
5/12/2021	Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
5/12/2021	Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
5/11/2021	April 2, 2021 Approval Letter - YESCARTA
5/11/2021	eSubmitter Application History
5/7/2021	CBER Vacancy: Staff Fellow/Visiting Associate: Pharmacology/Toxicology Reviewer
5/7/2021	April 22, 2021 Approval Letter - YESCARTA
5/6/2021	May 4, 2021 Untitled Letter - Ramos Chiropractic and Wellness Center (aka Rejuvenate Stem Cell Center)
5/3/2021	Complete List of Licensed Products and Establishments
5/3/2021	Complete List of Substantially Equivalent 510(k) Device Applications
5/3/2021	Complete List of Currently Approved Premarket Approvals (PMAs)
5/3/2021	Complete List of Currently Approved NDA and ANDA Application Submissions
4/27/2021	A Method for Detection of SARS-CoV-2 RNA in Healthy Human Stool: A Validation Study
4/27/2021	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act