CDER, CBER ‘Hub’ aims at energizing rare disease regulation

Responding to demands from patient advocates, Congress and biopharma companies for a more consistent and focused approach to regulating medicines for rare conditions, FDA Wednesday announced the establishment of a Rare Disease Innovation Hub.

Rare disease advocates have been calling for years for FDA to create a center of excellence dedicated to rare diseases, a move FDA leadership has resisted. The hub is intended to address many of the issues that fueled calls for a center of excellence, especially inconsistencies between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, and within the centers, on the oversight of orphan drugs...