Personalized medicine does not fit easily into established government procedures for approving drugs. After all, clinical trials are designed to test a drug on a large and diverse group of patients, and the whole point of personalized therapeutics is to target the specific genetic populations that will benefit most. The U.S. Food and Drug Administration is now trying to figure out how to judge the usefulness of a drug designed for particular genetic groups while also considering its safety for others who may receive it for off-label purposes.COURTNEY HUMPHRIES
Technology Review
