What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 03/24/2020

• March 23, 2020 Approval Letter - VAXELIS
• Investigational COVID-19 Convalescent Plasma - Emergency INDs

3/24/2020	March 23, 2020 Approval Letter - VAXELIS
3/24/2020	Investigational COVID-19 Convalescent Plasma - Emergency INDs
3/23/2020	March 20, 2020 Approval Letter - Typhim Vi
3/23/2020	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
3/20/2020	March 20, 2020 Approval Letter - Fluarix Quadrivalent
3/19/2020	Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
3/18/2020	Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays
3/18/2020	March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.
3/18/2020	March 13, 2020 Approval Letter - ALBAclone STN#125309-64
3/16/2020	eSubmitter Application History
3/16/2020	Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement
3/13/2020	Update 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
3/13/2020	BK190430 - Anti-D Donor Management and Inventory System (ADIMS)
3/13/2020	BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports
3/13/2020	CBER-Regulated Products: Resolved Shortages
3/12/2020	Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
3/12/2020	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
3/12/2020	Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry
3/11/2020	Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
3/11/2020	BK190434 - ORTHO CONNECT 3.0
3/11/2020	Regulatory Submissions - Electronic and Paper
3/3/2020	Complete List of Licensed Products and Establishments
3/3/2020	Complete List of Substantially Equivalent 510(k) Device Applications
3/3/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
3/3/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
3/2/2020	Statistical Review - FLUAD QUADRIVALENT
3/2/2020	February 20, 2020 Clinical Review - FLUAD QUADRIVALENT
2/27/2020	February 26, 2020 Approval Letter - ODACTRA
2/25/2020	Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting
2/25/2020	Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D)
2/25/2020	Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability
2/25/2020	Allergenic Products Advisory Committee May 15, 2020 Meeting Announcement