FDA First-Cycle Approval Rate For NMEs Leaps To 50% In 2003
This article was originally published in Pharmaceutical Approvals Monthly
FDA’s efforts to increase first-cycle approvals appear to be paying off, with the agency showing a significant improvement in 2003 compared to 2002.
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As FDA rolls out its Good Review Management Principles – its attempt to improve FDA’s timely review of drug applications through professional best practices – the agency is stressing the importance of sponsors submitting complete applications to facilitate this process.
NDA and BLA sponsors contribute to the need for multi-cycle reviews by failing to act on FDA recommendations made during development "milestone" meetings, according to an independent analysis of the agency’s first-cycle review performance.
Average time to approval rose in 2004 to 18.7 months for NMEs, but biologics average was significantly lower at 20.2 months. 2003 averages were 17.1 for drugs, 36.9 for biologics