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Generic Industry Wants More Guidance On Demonstrating Equivalence Of Drug-Device Combinations

 
• By Joanne S. Eglovitch

Firms want US FDA to better address how generic drug manufacturers can demonstrate similarity to innovator drug-device combination products.

The generic drug industry would like more guidance from FDA on its criteria for determining whether a proposed generic of a drug-device combination product is therapeutically equivalent or substitutable with its reference.

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