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US FDA prepares for biosimilars in 2011 budget plan, despite stalled reform bill
08 February 2010
Nancy Faigen
As part of the unveiling of the Obama administration's fiscal year 2011 budget,
FDA officials outlined how the agency plans to prepare for an approval pathway for follow-on biologics (or biosimilars), despite a lag in Congress moving to establish an explicit approval process. In total, the FDA seeks...
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08 February 2010
Nancy Faigen
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