In Focus: Compliance in the Global Setting

| 01 October 2011

By Mukesh Kumar, PhD, RAC
The last few years have seen the US Food and Drug Administration (FDA) become increasingly aggressive in monitoring the compliance status of the biopharmaceutical and medical device industries. Recently, the number of auditors in the Division of Scientific Investigations within the Office of Compliance was increased significantly to boost the number of inspections both domestically and internationally for all companies exporting regulated products to the US.


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