viernes, 11 de septiembre de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA



Posted: 9/10/2020






9/10/2020Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
9/10/2020September 9, 2020 Approval Letter - ODACTRA
9/10/2020Influenza Vaccine for the 2020-2021 Season
9/8/2020September 3, 2020 Untitled Letter - Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center, PC
9/8/2020eSubmitter Application History
9/3/2020Influenza Vaccine for the 2020-2021 Season
9/2/2020Recommendations for Investigational COVID-19 Convalescent Plasma
9/2/2020Investigational COVID-19 Convalescent Plasma; Guidance for Industry
9/2/2020Complete List of Licensed Products and Establishments
9/2/2020Complete List of Substantially Equivalent 510(k) Device Applications
9/2/2020Complete List of Currently Approved Premarket Approvals (PMAs)
9/2/2020Complete List of Currently Approved NDA and ANDA Application Submissions
8/27/2020Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement
8/27/2020August 27, 2020 Approval Letter - Afluria
8/27/2020Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
8/26/2020Influenza Vaccine for the 2020-2021 Season
8/26/2020Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
8/23/2020Coronavirus (COVID-19) | CBER-Regulated Biologics
8/23/2020Recommendations for Investigational COVID-19 Convalescent Plasma
8/21/2020August 20, 2020 Approval Letter - Gardasil 9
8/20/20202020 Biological Device Application Approvals
8/20/20202020 Biological License Application Approvals
8/20/2020Clinical Review - XYNTHA
8/20/2020Statistical Review - XYNTHA
8/19/2020Influenza Vaccine for the 2020-2021 Season
8/19/2020eSubmitter Application History
8/19/2020Recommendations for Investigational COVID-19 Convalescent Plasma
8/18/2020Updated Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/17/2020August 13, 2020 Approval Letter - XYNTHA
8/17/2020August 14, 2020 Approval Letter - RotaTeq
8/14/2020Novel Methods to Detect Malaria Biomarkers for Evaluation of Vaccine Safety and Efficacy
8/14/2020Immunogenicity of Gene Therapy Products
8/14/2020August 12, 2020 Summary of the Safety and Effectiveness - cobas HIV-1/HIV-2 Qualitative
8/13/2020August 12, 2020 Approval Order - cobas HIV-1/HIV-2 Qualitative
8/13/2020August 11, 2020 Untitled Letter - East West Health Solutions, Inc.
8/12/2020July 23, 2020 Summary Basis for Regulatory Action - TECARTUS
8/12/2020Influenza Vaccine for the 2020-2021 Season
8/12/2020CBER-Regulated Products: Resolved Shortages
8/11/2020Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement

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