Blog

Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?

March 27, 2018

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Submitting IND safety reports to an IND in eCTD format is slightly different...

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Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA

March 1, 2018

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission...

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Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

January 22, 2018

By: Robert McNeill, Ph.D., Scientist In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for...

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South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

January 17, 2018

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World, South Africa On 01 June 2017,...

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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),...

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Precision Medicine and the FDA

October 20, 2016

by Reshma Jagasia, Ph.D., Scientist “Doctors have always recognized that every patient is unique, and doctors have always tried to...

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