What’s New for Biologics | FDA

What’s New for Biologics | FDA

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.
4/16/2020	Summary of Safety and Effectiveness-Elecsys HIV Duo
4/16/2020	2020 Biological License Application Approvals
4/16/2020	2020 Biological License Application Supplement Noteworthy Approvals
4/16/2020	2020 Biological Device Application Approvals
4/15/2020	April 14, 2020 Approval Letter - FluMist
4/10/2020	April 10, 2020 Approval Letter - Elecsys HIV Duo
4/9/2020	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
4/9/2020	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
4/8/2020	Recommendations for Investigational COVID-19 Convalescent Plasma