USA – FDA unveils rare disease innovation hub, plans public meeting this fall

The US Food and Drug Administration (US) announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation of drugs and biologics, and engage patient advocacy communities. The Rare Disease Innovation Hub, or “the Hub”, will focus on diseases that are not fully understood and where development of treatments is “particularly challenging”, the agency explained. It will be co-led by Center for Biologics Evaluation and Research Director Peter Mar...