Search Results for foreign drug inspections

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FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

Categories: News, Europe, US, FDA, MHRA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: foreign drug inspections, foreign device inspections

Califf Vows Not to Lower or Remove FDA Regulations By Zachary Brennan - Published 11 January 2016

President Barack Obama’s US Food and Drug Administration (FDA) commissioner nominee Robert Califf, who faces a Senate committee vote Tuesday, told legislators in written comments that he does not support the lowering or removal of regulations at FDA, though he previously said they were a barrier to innovation.

Categories: Biologics and biotechnology, Compliance, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices

Tags: Califf, FDA, quality metrics, foreign drug inspections, Lamar Alexander