What’s New for Biologics | FDA

What’s New for Biologics | FDA

9/3/2020	Influenza Vaccine for the 2020-2021 Season
9/2/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
9/2/2020	Investigational COVID-19 Convalescent Plasma; Guidance for Industry
9/2/2020	Complete List of Licensed Products and Establishments
9/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
9/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
9/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
8/27/2020	Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement
8/27/2020	August 27, 2020 Approval Letter - Afluria
8/27/2020	Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
8/26/2020	Influenza Vaccine for the 2020-2021 Season
8/26/2020	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
8/23/2020	Coronavirus (COVID-19) | CBER-Regulated Biologics
8/23/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
8/23/2020	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
8/21/2020	August 20, 2020 Approval Letter - Gardasil 9
8/20/2020	2020 Biological Device Application Approvals
8/20/2020	2020 Biological License Application Approvals
8/20/2020	Clinical Review - XYNTHA
8/20/2020	Statistical Review - XYNTHA
8/19/2020	Influenza Vaccine for the 2020-2021 Season
8/19/2020	eSubmitter Application History
8/19/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
8/18/2020	Updated Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/17/2020	August 13, 2020 Approval Letter - XYNTHA
8/17/2020	August 14, 2020 Approval Letter - RotaTeq
8/14/2020	Novel Methods to Detect Malaria Biomarkers for Evaluation of Vaccine Safety and Efficacy
8/14/2020	Immunogenicity of Gene Therapy Products
8/14/2020	August 12, 2020 Summary of the Safety and Effectiveness - cobas HIV-1/HIV-2 Qualitative
8/13/2020	August 12, 2020 Approval Order - cobas HIV-1/HIV-2 Qualitative
8/13/2020	August 11, 2020 Untitled Letter - East West Health Solutions, Inc.
8/12/2020	July 23, 2020 Summary Basis for Regulatory Action - TECARTUS
8/12/2020	Influenza Vaccine for the 2020-2021 Season
8/12/2020	CBER-Regulated Products: Resolved Shortages
8/11/2020	Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement
8/7/2020	BK200449 – Healeon Duet
8/5/2020	Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/5/2020	Influenza Vaccine for the 2020-2021 Season