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.
FDA's Revised Strategic Plan Emphasizes Countermeasures, Biosimilars
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.
CMS 2012 Budget Looks To Biosimilars, Brand/Generic Deals To Offset Costs
In its 2012 budget proposal for the Centers for Medicare and Medicaid Services, the Obama administration casts its net wide to find potential savings from prescription drug spending to help offset Medicare and Medicaid costs.