Items related to biologics will be added to the top of the list as they are posted on the site.
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
4/30/2021
CBER Vacancy: Staff Fellow/Visiting Associate: Scientific Reviewer
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
4/26/2021
2021 Biological License Application Approvals
4/26/2021
2021 Biological License Application Supplement Noteworthy Approvals
4/26/2021
2021 Biological Device Application Approvals
4/26/2021
April 20, 2021 Approval Letter - BeneFIX
4/26/2021
April 23, 2021 Approval Letter - Hizentra
4/23/2021
Model Informed Drug Development Approaches for Immunogenicity Assessments
4/22/2021
April 19, 2021 Approval Letter - Blood Grouping Reagents Anti-D, Anti-Fya, Anti-S, Anti-K
4/22/2021
Clinical Review Memorandum - RAGWITEK
4/22/2021
Statistical Review - RAGWITEK
4/21/2021
BK210563 - Royal Maxx Autologous PRP Concentration System
4/21/2021
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
4/20/2021
BK210556 - Sunquest Transfusion Manager Version 3.0
4/19/2021
April 16, 2021 Approval Letter - RAGWITEK
Content current as of:
05/17/2021