PharmacoEconomics & Outcomes News 561 - 6 Sep 2008 US FDA sets its sights on the developing world A new US FDA proposal would see inspection offices established in five regions of the developing world to enable the agency to better monitor the safety of drugs, food and medical devices being exported to the US. A funding increase was proposed recently, * for this expansion, with a total proposed increase in FDA funding over the previous fiscal year now topping $US404 million, a 17.8% rise. Asia, India, Central America, South America and the Middle East are the regions targeted for the new FDA presence. Inspections are already carried out by the agency in Canada, with the FDA and Health Canada having an arrangement under which an auditor from one of the agencies conducts inspections on behalf of both: the FDA is now negotiating a similar arrangement with the European Union. * See PharmacoEconomics & Outcomes News 560, p 10; 801108088 Kondro W. FDA goes global. CMAJ: Canadian Medical Association Journal 179: 131, No. 2, 15 Jul 2008 801122194 1 PharmacoEconomics & Outcomes News 6 Sep 2008 No. 561 1173-5503/10/0561-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

US FDA sets its sights on the developing world

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PharmacoEconomics & Outcomes News 561 - 6 Sep 2008

US FDA sets its sights on thedeveloping world

A new US FDA proposal would see inspection officesestablished in five regions of the developing world toenable the agency to better monitor the safety of drugs,food and medical devices being exported to the US.

A funding increase was proposed recently,* for thisexpansion, with a total proposed increase in FDAfunding over the previous fiscal year now topping$US404 million, a 17.8% rise. Asia, India, CentralAmerica, South America and the Middle East are theregions targeted for the new FDA presence. Inspectionsare already carried out by the agency in Canada, with theFDA and Health Canada having an arrangement underwhich an auditor from one of the agencies conductsinspections on behalf of both: the FDA is nownegotiating a similar arrangement with the EuropeanUnion.* See PharmacoEconomics & Outcomes News 560, p 10; 801108088

Kondro W. FDA goes global. CMAJ: Canadian Medical Association Journal 179:131, No. 2, 15 Jul 2008 801122194