FDA Offers 2016 Report on Medical Countermeasure Activities
By Zachary Brennan -
Published 20 March 2017
As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.
Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality
Tags: medical countermeasures, Ebola, Zika, flu vaccine
Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016)
By Nick Paul Taylor -
Published 12 April 2016
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Categories: News, Asia, CDSCO, CFDA, TGA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices
Tags: DCGI, Asia Regulatory Roundup, device clinical trials, flu vaccine in Australia
FDA Chides GSK Subsidiary for Flu Vaccine Manufacturing Troubles
By Alexander Gaffney, RAC -
Published 24 June 2014
A Canadian subsidiary of pharmaceutical company GlaxoSmithKline (GSK) has been accused by the US Food and Drug Administration (FDA) of deviating from good manufacturing practice (GMP) regulations while manufacturing the flu vaccine FluLaval.
Categories: News, Canada, US, CBER, Biologics and biotechnology, Compliance, Manufacturing, Quality
Tags: Warning Letter, Inspection, Vaccine, Flu Vaccine, Influenza Vaccine, FluLaval