Posts tagged Catalyst Pharms.
Blogs
7 minute read
On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1] In brief, the Catalyst decision by the 11th Circuit Court of Appeals[2] concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”
Blog Editors
Recent Updates
- DEA Issues Third Extension to Public Health Emergency Telemedicine Prescribing Flexibilities, Through 2025
- CMS Issuing First Risk Adjustment Data Validation Audit Notices for PY2018 Since the RADV Final Rule
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates
- Post-Hurricane Flexibilities Offered by the U.S. Department of Health and Human Services Through the Centers for Medicare & Medicaid Services