What’s New for Biologics | FDA

What’s New for Biologics | FDA

CBER-Regulated Products: Current Shortages Posted: 11/13/2019 November 12, 2019 Approval Letter - Rotarix Posted: 11/13/2019

11/14/2019	Influenza Vaccine for the 2019-2020 Season
11/13/2019	November 12, 2019 Approval Letter - Rotarix
11/13/2019	CBER-Regulated Products: Current Shortages
11/12/2019	BK190349 - RD2 System
11/7/2019	BK190406 - Arthrex Double Syringe (ACP) kit
11/7/2019	BK180296 - Fidia PRP Kit
11/6/2019	Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Discussion Topics
11/6/2019	November 6, 2019 Approval Letter - INFANRIX
11/6/2019	November 6, 2019 Approval Letter - PEDIARIX
11/6/2019	November 6, 2019 Approval Letter - KINRIX
11/5/2019	November 5, 2019 Grant Order - Sentosa SQ HIV-1 Genotyping Assay
11/5/2019	Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS)
11/4/2019	November 4, 2019 Approval Letter - Fluzone High-Dose Quadrivalent
11/4/2019	SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/4/2019	Complete List of Currently Approved NDA and ANDA Application Submissions
11/4/2019	Complete List of Currently Approved Premarket Applications (PMAs)
11/4/2019	Complete List of Substantially Equivalent 510(k) Device Applications
11/4/2019	Complete List of Licensed Products and Establishments
10/31/2019	Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile - Agenda
10/29/2019	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
10/28/2019	October 25, 2019 Approval Letter - IMOVAX
10/28/2019	2019 Biological License Application Supplement Noteworthy Approvals
10/28/2019	2019 Biological License Application Approvals
10/28/2019	2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
10/28/2019	2019 Biological Device Application Approvals
10/25/2019	October 25, 2019 Approval Letter - ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION, USP
10/25/2019	Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile - Agenda
10/25/2019	October 24, 2019 Approval Letter - BEXSERO
10/24/2019	CBER-Regulated Products: Resolved Shortages
10/21/2019	Clinical Investigator Status (Biologics)
10/17/2019	September 24, 2019 Summary Basis for Regulatory Action - JYNNEOS
10/16/2019	BK190379 - DG Reader Net
10/16/2019	CBER Vacancy: Associate Director for Medical Policy – Title 38(F) Physician (GP-0602-15)
10/16/2019	Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document
10/16/2019	Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
10/15/2019	October 15, 2019 Approval Letter - Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
10/15/2019	October 11, 2019 Approval Letter - Reagent Red Blood Cells - STN# 103898
10/15/2019	October 11, 2019 Approval Letter - DG Gel Cards - STN# 125449/55 et. al.
10/15/2019	October 11, 2019 Approval Letter - DG Gel 8 (Anti-Human Globulin) - STN# 125445/37