lunes, 22 de junio de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA



6/19/2020June 19, 2020 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine Live
6/19/2020June 18, 2020 Approval Letter - Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)(For Further Manufacturing Use)
6/19/2020June 18, 2020 Approval Letter - Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)(For Further Manufacturing Use)
6/19/2020BK190356 - PrepaCyte-CB Processing System
6/18/2020eSubmitter Application History
6/16/2020BK200474 - NEO Iris
6/16/2020June 12, 2020 Approval Letter - Referencells
6/16/2020June 12, 2020 Approval Letter - Panoscreen and Panoscreen Extend
6/16/20202020 Biological License Application Supplement Noteworthy Approvals
6/16/20202020 Biological Device Application Approvals
6/16/2020CBER Vaccine ICSR Implementation
6/16/2020CBER Vaccine ICSR (Legacy) Implementation
6/16/2020Getting Started with ICSR Submission of FDA's electronic Vaccines Adverse Event Reporting System (eVAERS)
6/16/2020Electronic Submission of Postmarket Safety Reports
6/15/2020BK200479 - WellSky Blood - Emergency Issue 2020 R1
6/15/2020June 12, 2020 Approval Letter - Gardasil 9
6/12/2020Regenerative Medicine Fellowship under the Service Fellowship Program for CBER
6/11/2020Assessing Immunogenicity of Products for Gene Therapy and T cell Therapy
6/11/2020Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell-Based Products
6/11/2020June 9, 2020 Approval Letter - Kedbumin
6/11/2020BK200475 - ALYX Component Collection System
6/11/2020BK200482 - Blood Product Administration Module Version 3-2020
6/9/2020BK190393 - Aeon CPKit
6/5/2020New Approaches to the Development and Evaluation of Human Cytomegalovirus (HCMV) Vaccines
6/3/2020OraQuick In-Home HIV Test Fact Sheet
6/1/2020Complete List of Licensed Products and Establishments
6/1/2020Complete List of Substantially Equivalent 510(k) Device Applications
6/1/2020Complete List of Currently Approved Premarket Approvals (PMAs)
6/1/2020Complete List of Currently Approved NDA and ANDA Application Submissions
5/28/2020Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
5/27/2020May 14, 2020 Approval Letter - CUTAQUIG
5/27/2020May 18, 2020 Approval Letter - YESCARTA
5/22/2020Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens
5/21/2020BK200472 - BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle
5/21/2020HCT/P Inspection Information
5/19/2020Annual Summary for Fiscal Year 2019
5/19/2020Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
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