Blog

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

July 14, 2017

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist The International Conference on Harmonization (ICH) last updated its guidance “THE...

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Compassionate Use: providing cancer care outside trials

May 2, 2017

Being a challenging and arduous operation, finding new therapies to treat cancer often is a time-consuming process. For some patients, marketed...

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CANCER IMMUNOTHERAPY: A NEW HOPE

March 23, 2017

By Reshma Jagasia, Ph.D, Scientist at Cato Research The current standard of care for cancer treatment is surgery, chemotherapy, and...

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A New Expedited Review Designation: Regenerative Advanced Therapy

February 9, 2017

By Michelle Villasmil, Ph.D., RAC (U.S.), Regulatory Scientist One of the many changes brought by the 21st Century Cures Act...

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Transparency Initiatives at Health Canada

January 4, 2017

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),...