A pharma company sought to expand its drug label to a new patient population without relying on traditional RCTs. IQVIA’s Regulatory Science and Strategy team guided the process using a Real-World Evidence study. They developed a detailed protocol synopsis, prepared a Type B FDA meeting request and briefing package to justify the study design and data source, and later created a Type D briefing package to address FDA feedback. This Type D meeting, one of the first of its kind, highlighted IQVIA’s regulatory expertise. The approach enabled clear FDA engagement, robust evidence positioning, and progress toward label expansion.

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