What’s New for Biologics | FDA

What’s New for Biologics | FDA

November 5, 2019 Grant Order - Sentosa SQ HIV-1 Genotyping Assay

Posted: 11/5/2019

Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS)

Posted: 11/5/2019

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
11/4/2019	Complete List of Currently Approved Premarket Applications (PMAs)
11/4/2019	Complete List of Substantially Equivalent 510(k) Device Applications
11/4/2019	Complete List of Licensed Products and Establishments
10/31/2019	Influenza Vaccine for the 2019-2020 Season
10/31/2019	Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile - Agenda