Industry proposes review changes for genomics-based drugs

06/8/2006 | Drug Store News

Drugmakers offered the acting FDA commissioner Andrew von Eschenbach several regulatory changes they need to develop new products based on genomics. Among the proposals were: integrating biomarker validation into all stages of FDA review; assessing safety and effectiveness for specific populations at specific doses; and using a single standard for collecting and using data from electronic medical records.

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