What’s New for Biologics | FDA

What’s New for Biologics | FDA

5/21/2020	BK200472 - BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle
5/21/2020	HCT/P Inspection Information
5/19/2020	Annual Summary for Fiscal Year 2019
5/19/2020	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
5/18/2020	2020 Biological License Application Approvals
5/18/2020	2020 Biological Device Application Approvals
5/14/2020	April 28, 2020 Untitled Letter - ValeoMD
5/14/2020	May 13, 2020 Approval Letter - FLUAD
5/14/2020	April 22, 2020 Summary Basis for Regulatory Action - MenQuadfi
5/13/2020	May 12, 2020 Approval Letter - Flublok
5/12/2020	May 11, 2020 Untitled Letter - Sparrow Health & Performance, LLC
5/12/2020	Transcript for the Facilitating End-to-End Development of Individualized Therapeutics Public Workshop
5/12/2020	May 11, 2020 Approval Letter - Anti - M (Murine Monoclonal IgG) STN#125308-56
5/12/2020	eSubmitter Application History
5/11/2020	Updated Information for Blood Establishments Regarding the Novel Coronavirus (COVID-19) Outbreak
5/11/2020	CBER-Regulated Products: Resolved Shortages
5/10/2020	May 7, 2020 Approval Letter - Blood Grouping Reagent Anti-e P3GD512 + MS16 + MS21 + MS63
5/8/2020	BK200478 - Aurora Xi Plasmapheresis System
5/8/2020	BK190313 - PK System Control
5/8/2020	May 7, 2020 Approval Letter - Reagent Red Blood Cells A1 Cells / B Cells
5/8/2020	May 7, 2020 Approval Letter - Blood Grouping Regents Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-D (PK 1), Anti-D (PK 2), Anti-E, Anti-e, Anti-C, Anti-c, and Anti-K
5/8/2020	BK180292 - PK7400 Automated Microplate System
5/7/2020	May 5, 2020 Approval Letter - VAXELIS
5/6/2020	April 27, 2020 Untitled Letter - Henry N. Small, MD, PA
5/6/2020	May 6, 2020 Approval Letter - HEPLISAV-B
5/5/2020	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
5/4/2020	May 1, 2020 Approval Order - INTERCEPT Blood System for Plasma
5/4/2020	April 28, 2020 Untitled Letter - BrioMD
5/4/2020	Complete List of Licensed Products and Establishments
5/4/2020	Complete List of Substantially Equivalent 510(k) Device Applications
5/4/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
5/4/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
5/1/2020	Investigational COVID-19 Convalescent Plasma; Guidance for Industry (Updated: May 1, 2020)
5/1/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
4/30/2020	Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19 (update)
4/28/2020	April 27, 2020 Untitled Letter - Infuze MD
4/28/2020	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
4/27/2020	BK200467- Erytra Eflexis
4/27/2020	April 10, 2020 Untitled Letter - Regenerative Solutions of New Jersey
4/24/2020	Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19 (update)
4/24/2020	CBER Vacancy: Staff Fellow/Visiting Associate: Viral Vaccines
4/24/2020	April 23, 2020 Approval Letter - MenQuadfi
4/24/2020	April 23, 2020 Approval Letter - Anti-D (RH1) IgM/IgG
4/23/2020	April 21, 2020 Approval Letter - AFSTYLA
4/22/2020	Clinical Investigator Status (Biologics)
4/22/2020	Coronavirus (COVID-19) | CBER-Regulated Biologics
4/21/2020	BK200456 - GeTraP
4/20/2020	April 10, 2020 Untitled Letter - Kimera Labs, Inc.