FDA's Budget Path To Biosimilars: 21 Applications By 2015?
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A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.
Other aspects of FDA's approach to drugs and biologics remain the same as they were in last September's draft version of the agency's five-year plan.
FDA's proposed fiscal year 2012 budget provides a modest 7% increase in federal appropriations for the human drugs program, which also will benefit from a hefty 46% increase in PDUFA user fees.