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Abstract：
BACKGROUND: Prior studies suggested that holding preinvestigational new drug application (PIND) meetings with FDA has a positive effect on clinical development time (CDT).
METHODS: New product marketing applications submitted to FDA CDER during fiscal years 2008-2012 were assessed for whether a PIND meeting was held and, if so, a qualitative assessment of meeting content was performed.
RESULTS: Discussions contained in the PIND meeting minutes tended to reflect topics appropriate to an early phase of drug development, including chemistry, manufacturing, and controls (CMC) and safety topics (eg, nonclinical and clinical domains). Additionally, FDA commonly provided additional advice most often in the clinical and CMC domains. Applications for which a PIND meeting was held during drug development had shorter CDTs than those that did not.
CONCLUSIONS: This analysis showed the importance of early communication with FDA during development, and small companies with limited regulatory experience may gain the greatest benefit from early communication with FDA.
METHODS: New product marketing applications submitted to FDA CDER during fiscal years 2008-2012 were assessed for whether a PIND meeting was held and, if so, a qualitative assessment of meeting content was performed.
RESULTS: Discussions contained in the PIND meeting minutes tended to reflect topics appropriate to an early phase of drug development, including chemistry, manufacturing, and controls (CMC) and safety topics (eg, nonclinical and clinical domains). Additionally, FDA commonly provided additional advice most often in the clinical and CMC domains. Applications for which a PIND meeting was held during drug development had shorter CDTs than those that did not.
CONCLUSIONS: This analysis showed the importance of early communication with FDA during development, and small companies with limited regulatory experience may gain the greatest benefit from early communication with FDA.
摘要：
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