Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
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.
