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Generic Drug Pilot On Model-Informed Evidence Aims To Boost Review Efficiency

 
• By Derrick Gingery

US FDA officials, hoping to kick start participation in the pilot, argue modeling decisions made early in development can help streamline the ANDA review later.

car model
Clinical trial modeling could help generic drugs reach the market sooner. • Source: Shutterstock

US Food and Drug Administration officials emphasized the efficiency that its new Model-Integrated Evidence (MIE) pilot could create for generic drug sponsors in a bid to encourage participation.

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