Industry Skeptical Of User Fee Success, PricewaterhouseCoopers Finds
FDA may be wondering whether a lack of praise for its user fee program actually could be a criticism after a survey did not find overwhelmingly agreement the dollars were serving their intended purpose.
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PwC Health Research Institute’s survey of 100 senior executives found 43% support FDA use of economic data in deciding whether to approve a drug, up from 14% four years ago.
House oversight committee hears plea for more transparent, predictable regulatory processes at FDA.
Few, But Fast And On Time: 2010 Saw Low NME Count, But Almost All Were First-Cycle Approvals And FDA Met Most User Fees
The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.