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(HealthNewsDigest.com) – There’s a lot happening these days with regard to the personalization of medicine and how drugs work differently in people, particularly in men versus women. FDA has a long history in understanding and analyzing these effects.
We’ve issued guidance to the pharmaceutical industry explaining in detail our expectations about analyzing clinical data for sex-related differences as well as differences according to other demographic groupings. Those assessments, depending on the drug, may start with routine animal studies, in case a difference is evident by sex, but become most important when drugs begin to be tested in humans to see if data signal potential differences that require follow-up.
Read the entire blog at FDA Voice.
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