Pathway to Global Product Safety and Quality
DIANE Publishing, Oct 7, 2012 - 36 pages
This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.
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achieve activities borders building CAGR capabilities in intelligence China coalitions of regulators complex counterfeiting countries decade developing domestic drug manufacturing economic efforts entry Espicom Business Intelligence expand its capabilities facility inspections FDA import data FDA will continue FDA-regulated products focus food and medical food imports foreign counterparts foreign inspections Frost & Sullivan FSMA global coalitions global product safety global safety global supply chains growing growth in imports healthcare heparin ICAO identify IHS Global Insight import lines import refusals imports of FDA-regulated increased increasingly India industry intelligence gathering medical products Medicare melamine million OECD operating model oversight paradigm shift partners Pathway to Global percent pharmaceutical products PIC/S private third parties Project team analysis public and private public health regulated products regulatory risk models safety and quality safety standards seafood shipments Source stakeholders trends U.S. consumers U.S. food safety volume of imported