What’s New for Biologics | FDA

What’s New for Biologics | FDA

Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Discussion Topics

Posted: 11/6/2019

November 6, 2019 Approval Letter - INFANRIX

Posted: 11/6/2019

November 6, 2019 Approval Letter - PEDIARIX

Posted: 11/6/2019

November 6, 2019 Approval Letter - KINRIX

Posted: 11/6/2019

11/7/2019	BK180296 - Fidia PRP Kit
11/6/2019	Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Discussion Topics
11/6/2019	November 6, 2019 Approval Letter - INFANRIX
11/6/2019	November 6, 2019 Approval Letter - PEDIARIX
11/6/2019	November 6, 2019 Approval Letter - KINRIX
11/5/2019	November 5, 2019 Grant Order - Sentosa SQ HIV-1 Genotyping Assay
11/5/2019	Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS)
11/4/2019	November 4, 2019 Approval Letter - Fluzone High-Dose Quadrivalent
11/4/2019	SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/4/2019	Complete List of Currently Approved NDA and ANDA Application Submissions