Blog
Expansion Cohorts In Clinical Trials Of Oncology Drugs: FDA Issues Guidance
FDA released the final guideline paper in March for first-in-human trial models that include both dosage escalation and various expansion cohorts to assess safety, anti-tumor
May 16, 2022
Navigating Genomic Therapy Development
Research on genomic medicine is growing rapidly, which raises challenges concerning the design of clinical trials, regulatory channels, manufacturing processes, and price structures. Sandy Macrae,
May 14, 2022