Implications of Food and Drug Administration accelerated approval to a treatment for patients whose cancers have a specific genetic feature
“The U.S. Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.” What are the implications of this decision for diagnostic companies and for drug developers? Discuss at least one for each industry.
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