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Creating a workable generic drug user fee programme in the US

This article was originally published in SRA

Executive Summary

Generic medicines are a critical component of the US healthcare system. Access to low-cost generic prescription drugs allows millions of Americans to comply with their doctors' medication orders while saving billions of dollars in costs. But the growth of the generics industry, coupled with a chronic lack of resources for the Food and Drug Administration's Office of Generic Drugs, has created a situation that neither the industry nor the agency considers acceptable.

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