Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments

Resumo

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting, entitled "Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub." The purpose of the public meeting is to discuss the establishment of a Rare Disease Innovation Hub, which will enhance collaboration and cooperation across the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), as well as other centers and offices across FDA, to advance rare disease therapies. In particular, this meeting will be an opportunity for those in the rare disease community, including patients and caregiver groups, industry organizations, and scientific/academic organizations, to provide input on the priorities of the Rare Disease Innovation Hub and how the Hub can best engage with members of the rare disease community. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA.