FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies
Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist The International Conference on Harmonization (ICH) last updated its guidance “THE...
Compassionate Use: providing cancer care outside trials
Being a challenging and arduous operation, finding new therapies to treat cancer often is a time-consuming process. For some patients, marketed...
CANCER IMMUNOTHERAPY: A NEW HOPE
By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and...
A New Expedited Review Designation: Regenerative Advanced Therapy
By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist One of the many changes brought by the 21st Century Cures Act...
Transparency Initiatives at Health Canada
By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy. As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php),...