Abstract
Advancing the science of creating tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products, a working definition for Regulatory Science by the Food and Drug Administration (FDA), aligns closely with the Food Safety Modernization Act (FSMA). Intertwined within this definition and implicit within FSMA is a focus on standardization for industry and regulatory agencies alike. As food establishments seek to conform to regulatory requirements within this Act, a parallel activity is underway within the regulatory community involving standardization.
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