Regulations Enable Approvals and Opportunities in Rare Disease Drug Development - McDermott Will & Emery

Regulations Enable Approvals and Opportunities in Rare Disease Drug Development

Overview


Khelin Aiken commented on the US Food and Drug Administration’s steps to increase patient participation in rare disease clinical trials. “With respect to rare disease clinical trials, the biggest impact on patient recruitment is the challenge of finding subjects that are appropriate for inclusion because of the limited number of people that are suffering from the disease, thus making the pool of potential participants smaller.”