First Cycle Approval Rate Tops 50% For 2006 NMEs; Merck Hits 100%
Merck skillfully navigated FDA's approval process in 2006, receiving all five of its new molecular entity and novel biologic approvals after only a single review cycle
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As part of its recommendations for the renewal of the user fee program, FDA is proposing refinements to its "74-day letters" to give sponsors a more detailed schedule of how the application review will proceed
FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals
First-cycle approvals by FDA's Center for Drug Evaluation & Research may continue to rise for a second consecutive year, according to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007