An Evolving Regulatory Environment for Rare and Orphan Diseases
Advarra
AUGUST 16, 2022
A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.
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