Results for 'Biologics License'
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read