New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

May 16, 2018

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs)...


Exception from Informed Consent in Emergency Research

April 25, 2018

by Reshma Jagasia, Ph.D., Scientist by Nicole Tackmann, Ph.D., Clinical Strategy Intern All clinical investigations conducted in the United States...


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...


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...


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By: Robert McNeill, Ph.D., Scientist In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for...


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,...


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...


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...



March 23, 2017

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

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...