FDA Draft Guidance Calls For Trial Diversity Plans
Many companies have been signaling their commitment to diversity and inclusion in trials, but the new draft guidance spells out how they should address it and what the FDA wants to see.
You may also be interested in...
An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead.
House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.