1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US FDA's Office of New Drugs.

“Patients are increasingly recognised by all stakeholders as experts,” Lee said during a webinar on rare disease drug development hosted by the National Organization for Rare Disorders on 27 July. “If you look at the lifecycle of drug development, there are many aspects in which patient input should be sought early in the process.”

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