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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.

The industry also wants some clarity on other areas as well, such as what information should be submitted in generic drug applications and what information should be maintained at the...

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