Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials

Health Affairs

17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address unmet needs related to serious or life-threatening conditions. 

Drugs approved via this route rely on surrogate endpoints or other clinical indicators that are not direct measures of benefits to patients, such as survival or quality of life.

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Michael Wonder

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Michael Wonder