US EditionA Catalyst for Reform: Charting a Future for Orphan Drug Exclusivity - Penn Law Review
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A Catalyst for Reform: Charting a Future for Orphan Drug Exclusivity - Penn Law Review
Forty years after the passage of the Orphan Drug Act, the Catalyst Pharmaceuticals v. Becerra decision has ignited debate over the scope of orphan drug exclusivity. After a court ordered the U.S. Food & Drug Administration (FDA) to revoke its approval of a drug for a rare neuromuscular disorder, which it found violated another drugmaker’s market exclusivity, FDA countered by reaffirming its commitment to its own interpretation of the Orphan Drug…
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