FDA [to 2 July 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Summary Basis for Regulatory Action, June 10, 2016 – VAXCHORA (PDF – 258KB)
Posted: 7/1/2016

Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry (PDF – 174KB)
Posted: 6/30/2016

Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products
Posted: 6/29/2016

CBER Vacancy: Staff Fellow
Posted: 6/27/2016

FDA Information Regarding FluMist Quadrivalent Vaccine
Posted: 6/27/2016
…Based on data from observational studies showing lower than expected effectiveness of FluMist Quadrivalent from 2013 through 2016, on June 22, 2016, the Advisory Committee on Immunization Practices (ACIP), an advisory committee to the Centers for Disease Control and Prevention (CDC), voted to recommend that FluMist Quadrivalent should not be used during the 2016-2017 influenza season. FDA’s considerations regarding this vaccine are noted and explained below….