Rare Oncology Trials with Orphan Drug Status in the United States
Rare Oncology Trials with Orphan Drug Status in the United States Rare Oncology Trials in the U.S.: Navigating FDA Orphan Drug Designation and Regulatory Pathways Introduction Rare cancers represent a unique challenge in U.S. clinical research due to small patient populations, heterogeneity, and limited standard-of-care options. The Orphan Drug Act of 1983 provides critical incentives…
Read More “Rare Oncology Trials with Orphan Drug Status in the United States” »