What’s New for Biologics | FDA

What’s New for Biologics | FDA

FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance Posted 6/17/2019 June 14, 2019 Approval Letter - Alinity s HBsAg and Alinity s HBsAg Confirmatory Posted: 6/17/2019 2019 Biological Device Application Approvals Updated as of 5/31/2019; Posted: 6/17/2019 2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals Updated as of 5/31/2019; Posted: 6/17/2019 2019 Biological License Application Approvals Updated as of 5/31/2019; Posted: 6/17/2019

6/17/2019	FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance
6/17/2019	June 14, 2019 Approval Letter - Alinity s HBsAg and Alinity s HBsAg Confirmatory
6/17/2019	2019 Biological Device Application Approvals Updated as of 5/31/2019
6/17/2019	2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals Updated as of 5/31/2019
6/17/2019	2019 Biological License Application Approvals Updated as of 5/31/2019
6/14/2019	May 24, 2019 Summary Basis for Regulatory Action - ZOLGENSMA
6/14/2019	CBER Vacancy - Staff Fellow: Computer Scientist (RG-1550)
6/13/2019	Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
6/13/2019	Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry
6/13/2019	CBER-Regulated Products: Current Shortages Information on APLISOL