What’s New for Biologics | FDA

What’s New for Biologics | FDA

Clinical Investigator Status (Biologics) Posted: 10/21/2019

10/21/2019	Clinical Investigator Status (Biologics)
10/17/2019	Influenza Vaccine for the 2019-2020 Season
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.