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Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges

 
• By Sue Sutter

Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.

Small wave
A wave of drug and biologic lawsuits citing the Loper Bright decision is building. • Source: Shutterstock

Legal challenges of US Food and Drug Administration exclusivity determinations are among the early cases where the Supreme Court’s overturning of the Chevron doctrine of deference is being cited.

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