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),...
Precision Medicine and the FDA
by Reshma Jagasia, Ph.D., Scientist “Doctors have always recognized that every patient is unique, and doctors have always tried to...
The Current Implementation of the Drug Supply Chain Security Act (DSCSA) Implementation Plan and Rare Disease Drugs
What is the Drug Supply Chain Security Act (DSCSA)? In November 2013 the Drug Quality and Security Act (DQSA) was...
CIMT 2016 – Rise of mRNA therapeutics, a relatively new class of treatment
The increase of titles related to RNA-based therapeutics and vaccines within the CIMT poster session compared to previous years, highlighted...
CIMT 2016 “Mechanisms of efficacy in cancer immunotherapy”
For 14 years now, the largest meeting in Europe focused on cancer immunotherapies, the CIMT Annual Meeting, gathers the knowledge...
Jump on the Development Safety Update Report (DSUR) Bandwagon!
By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Canada. If you have an open Investigational New Drug application (IND) then...