FDA closes out series of patient-focused drug development guidance
The FDA on Wednesday released its fourth (of four) patient-focused drug development guidance documents, with this latest draft featuring long-awaited advice on how to collect and submit data on the individual experiences of patients to inform regulatory decisions.
So-called clinical outcome assessment (COA)-based endpoints feature prominently in the draft, with the FDA saying COAs are “intended to reflect, directly or indirectly, how patients feel, function, or survive.” But there are lots of dos and don’ts when it comes to COAs, and sponsors may frequently encounter challenges, many of which are outlined in the 45-page draft.
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