What’s New for Biologics | FDA

What’s New for Biologics | FDA

January 31, 2020 Summary Basis for Regulatory Action - AUDENZ Posted: 02/20/2020

2/20/2020	January 31, 2020 Summary Basis for Regulatory Action - AUDENZ
2/19/2020	January 31, 2020 Summary Basis for Regulatory Action - PALFORZIA
2/19/2020	2020 Biological Device Application Approvals
2/19/2020	2020 Biological License Application Supplement Noteworthy Approvals
2/19/2020	2020 Biological License Application Approvals
2/14/2020	Direct Recall Classification Program
2/14/2020	Electronic Submission of Biological Product Deviation Reports (eBPDR)
2/14/2020	Biological Product Deviations
2/14/2020	General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
2/14/2020	Instructions for Using the eBPDR System
2/14/2020	Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak
2/14/2020	February 13, 2020 Approval Letter - VAXCHORA
2/14/2020	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
2/13/2020	BK190317 - PurePRP SupraPhysiologic Concentrating System
2/13/2020	February 10, 2020 Untitled Letter - RejuvaYou Medical Corporation
2/13/2020	February 12, 2020 Approval Letter - Procleix Babesia Assay
2/13/2020	Blood Products Advisory Committee April 2-3, 2020 Meeting Announcement
2/13/2020	23rd US-Japan Cellular and Gene Therapy Conference
2/11/2020	eSubmitter Application History
2/11/2020	BK190413 - CompoMat G5 Plus and CompoMaster Net G5 Plus System
2/10/2020	January 17, 2020 Approval Letter - cobas MPX Test
2/7/2020	February 7, 2020 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
2/7/2020	February 6, 2020 Approval Letter - FluLaval
2/6/2020	CBER Vacancy: Staff Fellow/Visiting Associate – Vascular Biology
2/5/2020	Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry
2/4/2020	Complete List of Licensed Products and Establishments
2/4/2020	Complete List of Substantially Equivalent 510(k) Device Applications
2/4/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
2/4/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
2/4/2020	Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
2/3/2020	Facilitating End-to-End Development of Individualized Therapeutics
1/31/2020	January 31, 2020 Approval Letter - PALFORZIA
1/31/2020	January 31, 2020 Approval Letter - AUDENZ
1/31/2020	BK190429 - HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version)
1/30/2020	Clinical Review - Agriflu
1/30/2020	Statistical Review - Agriflu
1/30/2020	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry
1/29/2020	January 28, 2020 Approval Letter - Agriflu
1/28/2020	Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
1/28/2020	Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
1/28/2020	Human Gene Therapy for Retinal Disorders; Guidance for Industry
1/28/2020	Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
1/28/2020	Human Gene Therapy for Rare Diseases; Guidance for Industry
1/28/2020	Human Gene Therapy for Hemophilia; Guidance for Industry
1/28/2020	Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
1/24/2020	January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
1/24/2020	January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
1/23/2020	January 22, 2020 Approval Letter - DENGVAXIA
1/22/2020	BK190439 - MATCH IT! DNA (version 1.3)