Items related to biologics will be added to the top of the list as they are posted on the site.
12/1/2020
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act 11/30/2020
November 25, 2020 Approval Order - LIAISON XL MUREX HIV Ab/Ag HT and Control HIV Ab/Ag HT 11/25/2020
Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement 11/25/2020
November 24, 2020 Approval Order - INTERCEPT Blood System for Plasma 11/25/2020
Influenza Vaccine for the 2020-2021 Season 11/21/2020
Expiration Date Extension for 42 Cutaquig [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] Lots manufactured in 2019 and 2020 11/20/2020
BK200520 - DiaSpect system 11/20/2020
BK200526 - National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS) 11/20/2020
Emergency Use Authorization for Vaccines Explained 11/20/2020
Vaccine Development – 101 11/18/2020
Influenza Vaccine for the 2020-2021 Season 11/18/2020
Getting Started with ICSR Submission to FDA’s electronic Vaccine Adverse Event Reporting System (eVAERS) 11/18/2020
CBER Vaccine ICSR Implementation 11/17/2020
Coronavirus (COVID-19) | CBER-Regulated Biologics 11/17/2020
2020 Biological Device Application Approvals 11/17/2020
2020 Biological License Application Supplement Noteworthy Approvals 11/16/2020
Recommendations for Investigational COVID-19 Convalescent Plasma 11/16/2020
Investigational COVID-19 Convalescent Plasma; Guidance for Industry 11/12/2020
eSubmitter Application History 11/12/2020
BK200513 - e-Delphyn LIS Donor 11/12/2020
November 10, 2020 Untitled Letter - Regenerative Cell Institute LLC 11/10/2020
November 9, 2020 Approval Letter - TUBERSOL 11/9/2020
BK200517- GDS (Grifols Donation System) V2.0 11/9/2020
BK200515 - e-Delphyn Donor version 11.0.0.1 11/6/2020
Genome Editing and Advanced Manufacturing of Hematopoietic Stem Cell-Based Therapeutics 11/5/2020
Influenza Vaccine for the 2020-2021 Season 11/4/2020
October 29, 2020 Approval Letter - ALPROLIX 11/2/2020
Complete List of Licensed Products and Establishments 11/2/2020
Complete List of Substantially Equivalent 510(k) Device Applications 11/2/2020
Complete List of Currently Approved Premarket Approvals (PMAs) 11/2/2020
Complete List of Currently Approved NDA and ANDA Application Submissions 11/2/2020
October 30, 2020 Untitled Letter - Young Foundational Health Center, LLC 10/30/2020
Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs 10/30/2020
Influenza Vaccine for the 2020-2021 Season 10/28/2020
October 28, 2020 Approval Letter - Fluad and Fluad Quadrivalent 10/27/2020
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020 10/27/2020
October 27, 2020 Approval Letter - VAXELIS 10/27/2020
Gastrointestinal Viruses: Understanding Diversity and Immune Responses to Inform Vaccine Design 10/26/2020
October 23, 2020 Approval Letter - VAQTA 10/23/2020
BK200476 - PK CMV-PA System 10/22/2020
BK200512 - Regulated Software Application (RSA), Version 2.0 10/22/2020
Summary of Safety and Effectiveness - VioOne HIV Profile Supplemental Assay 10/22/2020
October 21, 2020 Approval Letter - Blood Grouping Reagent Anti-e 10/21/2020
Influenza Vaccine for the 2020-2021 Season 10/20/2020
October 19, 2020 Approval Order - VioOne HIV Profile Supplemental Assay
Content current as of:
12/01/2020
