What’s New for Biologics

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

6/17/2021	June 15, 2021 Untitled Letter - NatureWorks P.S.
6/17/2021	June 4, 2021 Summary Basis for Regulatory Action - RYPLAZIM
6/16/2021	June 14, 2021 Approval Letter - ADYNOVATE
6/15/2021	June 15, 2021 Approval Letter - STRATAGRAFT
6/14/2021	June 11, 2021 Approval Letter - KYMRIAH
6/10/2021	June 10, 2021 Approval Letter - PREVNAR 20
06/10/2021	CBER-Regulated Products: Resolved Shortages
06/9/2021	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021
6/8/2021	Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011
6/8/2021	eSubmitter Application History
6/7/2021	June 7, 2021 Approval Letter - JYNNEOS
6/7/2021	June 4, 2021 Approval Letter - RIASTAP
6/4/2021	June 4, 2021 Approval Letter - RYPLAZIM
6/4/2021	Regulatory Education for Industry (REdI) Annual Conference 2021
6/3/2021	Preclinical Pharm-Tox Review - KEDRAB
6/3/2021	Clinical Review Memo - KEDRAB
6/3/2021	Statistical Review Memo -KEDRAB
6/3/2021	Important Patient and Consumer Information About Regenerative Medicine Therapies
6/2/2021	BK210559 - Sysmex XN-10 Automated Hematology Analyzer
6/2/2021	CBER Expanded Access Submission Receipt Reports
6/1/2021	Complete List of Licensed Products and Establishments
6/1/2021	Complete List of Substantially Equivalent 510(k) Device Applications
6/1/2021	Complete List of Currently Approved Premarket Approvals (PMAs)
6/1/2021	Complete List of Currently Approved NDA and ANDA Application Submissions
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