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The Gray Sheet: FDA Long-Term Globalization Strategy Under Development

Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA’s own staff and more on data and resource sharing with other countries, the agency says.

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Bloomberg: More Outsourcing Planned for FDA Overseas Factory Inspections

U.S. regulators plan to outsource more inspections of overseas factories within the next decade after criticism from Congress about a lack of oversight for food and drugs made in other countries.

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FDA Webview: 2012 User Fee Legislation Likely to be Bipartisan

Reauthorization of FDA user fees, scheduled for consideration by Congress next year, is expected to pass on a largely bipartisan basis and is unlikely to involve the kind of political controversy currently surrounding the Obama administration’s healthcare legislation.

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Milwaukee Magazine: The new front on health care reform

Wisconsin Congresswoman Tammy Baldwin is a leader in the effort to reopen the national health care debate in the arena of critical care – emergency or life-sustaining care provided in emergency rooms or intensive care units. The effort is led by a national panel of specialists and advocates, the Roundtable on U.S. Critical Care Policy. A lobbying firm employed by the group says its members formed in part because they felt critical care was overlooked in the reform of America’s health care system.

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