viernes, 28 de agosto de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 8/27/2020


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
8/23/2020Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
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
8/7/2020BK200449 – Healeon Duet
8/5/2020Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/5/2020Influenza Vaccine for the 2020-2021 Season
8/4/2020Complete List of Licensed Products and Establishments
8/4/2020Complete List of Substantially Equivalent 510(k) Device Applications
8/4/2020Complete List of Currently Approved Premarket Approvals (PMAs)
8/4/2020Complete List of Currently Approved NDA and ANDA Application Submissions
8/3/2020BK200491 - iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0
8/3/2020Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
8/3/2020MedWatch to Manufacturer Program
7/31/2020CBER-Regulated Products: Resolved Shortages
7/31/2020CBER-Regulated Products: Current Shortages
7/28/2020Influenza neuraminidase antigenicity and efficacy in vaccines
7/28/2020July 28, 2020 Approval Letter - MENVEO
7/28/2020
7/28/2020User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
7/28/2020July 22, 2020 Untitled Letter - American Medical Aesthetics and Regenerative Medicine Inc.

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