What’s New Health Canada?

May 7, 2020

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: Biologics and Genetic Therapies Directorate:...


Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

April 29, 2020

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to...


Cancer, COVID-19, Continuity

April 29, 2020

The world is experiencing a major health care crisis. Thus far, over 2.5 million infections with severe acute respiratory syndrome...


Three blockbuster approved cancer drug launches expected in 2020

March 9, 2020

2019 has been an outstanding year for biotechnology companies developing anti-cancer drugs, as seen from the large number of approvals given by...


FDA & EMA Oncology Drugs and Diagnostics Recommended for Approval in 2019

January 16, 2020

2019 was a prolific year, yielding higher numbers of positive recommendations/approvalsthan 2018 for both the European Medicines Agency (EMA) and...


Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient

July 23, 2019

By Dieanira Erudaitius, Ph.D, Scientist This month, July 2019, the United States Food and Drug Administration (FDA) released a new...


New FDA Guidance on Natural History Studies for Rare Diseases

April 24, 2019

In a recent Ask Cato blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common...


Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

March 22, 2019

By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist On March 5, the FDA approved Spravato...


Lets talk about Patient Engagement

March 12, 2019

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are...


Revised FDA Guidance on Developing Rare Disease Therapies

February 28, 2019

by Kristen Biernat, Ph.D., Scientist Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose...