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. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
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