Biosimilars, Generic Programs Leave Little Room For Other New FDA Drug Initiatives In FY ‘13
Proposed and existing user fees would fund 44% of the $4.5 billion FDA FY 2013 spending plan. User fees are projected at $20 million for biosimilars and $229 million for generic drugs.
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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.
The Senate Appropriations Committee April 26 approves a $3.9 billion spending plan for the agency in fiscal 2013, providing a $12.5 million boost in Treasury spending over President Obama’s proposed budget, with the extra funds slated for the food and animal drug programs.
Analysis of drug review performance by division finds Cardiovascular & Renal Drugs Division to occupy the lower end of the spectrum. Staffing appears to be a vital component of review performance, giving weight to the researchers’ warning of impending wholesale staff turnover.