Search Results for flu vaccine

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European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

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