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ODE

Lachman Consultant Services, Inc. / Blog / ODE
23
Jan

FDA Takes a Stand on Orphan Drug Exclusivity in Unusual FR Notice

By Bob Pollock    Jan 23, 2023    FDA ODE Regulatory Affairs

The FDA has been walking a thin line on orphan drug exclusivity (ODE) ever since a September 30, 2021, ruling by the U.S. Court of Appeals for the Eleventh Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst), 14 F.4th 1299 (11th Cir. 2021).  in the pre-publication of today’s Federal Register, the FDA […]

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  • About
    ▼
    • Lachman Leadership Team
  • Areas Served
    ▼
    • Pharmaceutical
    • Medical Device/Combination Products
    • Biologics
    • Regulatory Affairs
  • Services
    ▼
    • Compliance
    • Data Integrity
    • Analytical Services
    • Biomonitoring Support
    • Strategic Planning
    • FDA-Related Services
    • Due Diligence Audits
    • Quality Assurance and Controls
    • Scientific and Technical Assistance
    • Systems Evaluation
    • Facilities Design or Validation
    • System Process Validation or Qualification
    • Training
    • Virtual Inspections
    • Remote Services From Lachman
    • Lachman OnCalltm GMP Teleconsulting
  • Markets
    ▼
    • Pharmaceuticals
    • Biotechnology
    • Biologics
    • Diagnostics
    • Generics
    • Combination Products
    • Medical Devices
    • Related Industries
  • Blog
  • News
  • Contact
    ▼
    • Schedule a Virtual Audit
  • Careers
    ▼
    • Career Opportunities
  • Resources
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