lunes, 23 de marzo de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA





3/23/2020March 20, 2020 Approval Letter - Typhim Vi
3/23/2020Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
3/20/2020March 20, 2020 Approval Letter - Fluarix Quadrivalent
3/19/2020Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
3/18/2020Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays
3/18/2020March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.
3/18/2020March 13, 2020 Approval Letter - ALBAclone STN#125309-64
3/16/2020eSubmitter Application History
3/16/2020Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement
3/13/2020Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/13/2020BK190430 - Anti-D Donor Management and Inventory System (ADIMS)
3/13/2020BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports
3/13/2020CBER-Regulated Products: Resolved Shortages
3/12/2020Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
3/12/2020Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/12/2020Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry
3/11/2020Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
3/11/2020BK190434 - ORTHO CONNECT 3.0
3/11/2020Regulatory Submissions - Electronic and Paper
3/3/2020Complete List of Licensed Products and Establishments
3/3/2020Complete List of Substantially Equivalent 510(k) Device Applications
3/3/2020Complete List of Currently Approved Premarket Approvals (PMAs)
3/3/2020Complete List of Currently Approved NDA and ANDA Application Submissions
3/2/2020Statistical Review - FLUAD QUADRIVALENT
3/2/2020February 20, 2020 Clinical Review - FLUAD QUADRIVALENT
2/27/2020February 26, 2020 Approval Letter - ODACTRA
2/25/2020Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting
2/25/2020Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D)
2/25/2020Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability
2/25/2020Allergenic Products Advisory Committee May 15, 2020 Meeting Announcement
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