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.”
Back to Health Law Advisor Blog
Recent Updates
- CMS Wants to End Certain COVID Requirements, Natural Light in Patient Care Areas: Proposed Rule Would Update CoPs for Hospitals, LTC Facilities, and Other Providers
- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know
- The Whistleblower Windfall? DOJ Announces Another Incentive Program for Reporting Fraud