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Exploring the US FDA's Upcoming Complex Generic Product-Specific Guidance Lists

 
• By Derrick Gingery

The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.

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The US FDA issued more revised than new product-specific guidances for generic products in fiscal year 2019, unlike past fiscal years. • Source: Shutterstock

Complex generic drug sponsors now can track the US Food and Drug Administration's plans for new and revised product-specific guidances and potentially avoid development or application assessment setbacks.

However, like the agency’s other guidance agendas, in many cases product-specific guidances (PSGs) have remained listed as upcoming or due...

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