What’s New for Biologics | FDA

What’s New for Biologics | FDA

7/9/2020	Regenerative Medicine Advanced Therapy Designation
7/7/2020	Summary of Safety and Effectiveness  - Alinity m HIV-1
7/6/2020	July 2, 2020 Approval Order - Alinity m HIV-1
7/6/2020	July 2, 2020 Approval Letter - Flucelvax
7/6/2020	July 2, 2020 Approval Letter - Fluad and Fluad Quadrivalent
7/6/2020	July 2, 2020 Approval Letter - FluLaval
7/2/2020	July 2, 2020 Approval Letter - Afluria
7/2/2020	July 2, 2020 Approval Letter - Fluarix Quadrivalent
7/2/2020	July 2, 2020 Approval Letter - Flublok
7/2/2020	July 2, 2020 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
7/2/2020	Influenza Vaccine for the 2020-2021 Season
7/2/2020	Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic
7/2/2020	Complete List of Licensed Products and Establishments
7/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
7/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
7/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
7/2/2020	Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
7/1/2020	Expiration Date Extension for MicRhoGAM (Rho(D) Immune Globulin) Lot MVP116A1 through July 19, 2021
6/30/2020	Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies
6/30/2020	Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
6/29/2020	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
6/26/2020	June 26, 2020 Approval Letter - BeneFIX
6/25/2020	Summary Basis for Regulatory Action - Blood Grouping Reagent, Anti-Lea, Anti-Leb
6/24/2020	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
6/24/2020	June 9, 2020 Clinical Review - GARDASIL 9
6/19/2020	June 19, 2020 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine Live
6/19/2020	June 18, 2020 Approval Letter - Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)(For Further Manufacturing Use)
6/19/2020	June 18, 2020 Approval Letter - Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)(For Further Manufacturing Use)
6/19/2020	BK190356 - PrepaCyte-CB Processing System
6/18/2020	eSubmitter Application History
6/16/2020	BK200474 - NEO Iris
6/16/2020	June 12, 2020 Approval Letter - Referencells
6/16/2020	June 12, 2020 Approval Letter - Panoscreen and Panoscreen Extend
6/16/2020	2020 Biological License Application Supplement Noteworthy Approvals
6/16/2020	2020 Biological Device Application Approvals
6/16/2020	CBER Vaccine ICSR Implementation
6/16/2020	CBER Vaccine ICSR (Legacy) Implementation
6/16/2020	Getting Started with ICSR Submission of FDA's electronic Vaccines Adverse Event Reporting System (eVAERS)
6/16/2020	Electronic Submission of Postmarket Safety Reports
6/15/2020	BK200479 - WellSky Blood - Emergency Issue 2020 R1
6/15/2020	June 12, 2020 Approval Letter - Gardasil 9
6/12/2020	Regenerative Medicine Fellowship under the Service Fellowship Program for CBER
6/11/2020	Assessing Immunogenicity of Products for Gene Therapy and T cell Therapy
6/11/2020	Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell-Based Products
6/11/2020	June 9, 2020 Approval Letter - Kedbumin
6/11/2020	BK200475 - ALYX Component Collection System
6/11/2020	BK200482 - Blood Product Administration Module Version 3-2020
6/9/2020	BK190393 - Aeon CPKit
6/5/2020	New Approaches to the Development and Evaluation of Human Cytomegalovirus (HCMV) Vaccines
6/3/2020	OraQuick In-Home HIV Test Fact Sheet