FDA Weighs Major Overhaul of Rare Disease Drug Approval! Patients Gain More Say, Drugmakers May See Clearer Regulatory Path

Zhito Finance APP has learned that the U.S. Food and Drug Administration (FDA) is launching a top-down comprehensive review to reassess its approach to rare disease drug development and approval. The FDA will announce the "Rare Disease Framework Initiative" on Wednesday. The initiative aims to establish a new system that gives patients a greater voice in the regulatory process while providing drug companies with a clearer regulatory pathway.