What’s New for Biologics | FDA

What’s New for Biologics | FDA

FY 2019 Report from the Director

Posted: 12/26/2019

12/26/2019	FY 2019 Report from the Director
12/23/2019	December 23, 2019 Approval Letter - Afluria and Afluria Quadrivalent
12/23/2019	BK190424 - IH-COM V5.2
12/23/2019	Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
12/20/2019	December 20, 2019 Approval Letter - MENVEO
12/20/2019	December 19, 2019 Approval Letter - ERVEBO
12/20/2019	Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document
12/20/2019	Important Information for Potential Donors of Blood and Blood Products
12/20/2019	TRG Rapid Inquiry Program (TRIP)
12/20/2019	BK190401 - ZipThaw™ 202
12/19/2019	BK190400 - MTS™ Buffered Gel Card
12/19/2019	BK190399 - ORTHO VISION Max Analyzer
12/19/2019	Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry
12/18/2019	December 17, 2019  Approval Letter - MTS Anti-IgG Card
12/18/2019	December 17, 2019 Approval Letter - ORTHO Sera
12/18/2019	2019 Biological Device Application Approvals
12/18/2019	2019 Biological License Application Supplement Noteworthy Approvals
12/16/2019	BK190388 - TANGO infinity
12/12/2019	Meeting Transcript - Advancing Scientific and Regulatory Approaches for Use and Development of Biomarkers for Preventative Vaccines Meeting - Tuesday, September 17, 2019
12/12/2019	BK190320 - DG Reader
12/12/2019	BK190321- WADiana Compact
12/12/2019	BK190318 - Erytra
12/11/2019	December 10, 2019 - Approval Letter - Anti-D (RH1) IgM/IgG 125621/2
12/11/2019	December 10, 2019 Approval Letter - DG Gel 8 Anti-IgG (Rabbit), DG Gel Cards - STN# 125445/32
12/11/2019	CBER Vacancy: Postdoctoral Fellow/Visiting Associate – Viral Vaccines (Biologist), RG-0401
12/9/2019	Complete List of Licensed Products and Establishments
12/9/2019	Complete List of Substantially Equivalent 510(k) Device Applications
12/9/2019	Complete List of Currently Approved Premarket Approvals (PMAs)
12/9/2019	Complete List of Currently Approved NDA and ANDA Application Submissions
12/9/2019	December 6, 2019 Approval Letter - TENIVAC
12/9/2019	BK190333 - Terumo Operational Medical Equipment Software (TOMEs), Version 7.1
12/9/2019	CBER-Regulated Products: Current Shortages
12/6/2019	Public Safety Notification on Exosome Products
12/5/2019	December 3, 2019 Approval Letter - Panoscreen EXTEND
12/5/2019	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
12/5/2019	Influenza Vaccine for the 2019-2020 Season
12/5/2019	Job Vacancy Announcement: Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)
12/4/2019	December 3, 2019 Approval Letter - Data-Cyte Plus 2, and Data-Cyte Extend  0.8 % Reagent Red Blood Cells
12/4/2019	BK190389 - ALBAcheck BGS Monoclonal Control
12/3/2019	November 25, 2019 Untitled Letter - Chara Biologics, Inc.
12/3/2019	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
12/2/2019	March 3, 2020 Workshop - Facilitating End-to-End Development of Individualized Therapeutics
11/29/2019	November 26, 2019 Approval Letter - Pneumovax 23
11/27/2019	November 25, 2019 Order to Cease Manufacturing - Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI)
11/27/2019	Influenza Vaccine for the 2019-2020 Season
11/25/2019	FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions