Current and Emerging Therapies for Patients With Multiple Myeloma
Multiple myeloma (MM) is a malignant disease of the bone marrow characterized by clonal expansion of plasma cells (1, 2)....
Improving Informed Consent in Clinical Trials
Does more information mean better knowledge? Authors: Ruth Cohen PhD, Regulatory Affairs Associate, CATO SMS Recruitment and retainment of patients...
New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings
By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Principles for...
New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings
By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Pediatric Study Plans:...
Immuno-oncology updates in the virtual era – ASCO 2020
This year’s ASCO Annual Scientific Meeting took place between May 29-31, with the Education Program planned for August 8-10. Unlike previous...
New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings
By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Development...
Are you ready for the new European clinical trial regulation?
The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in...
Clinical Research Regulation in the Netherlands
Before the first human subject receives an investigational medicinal product, the clinical trial has to be approved according to applicable...
What’s New Health Canada?
By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate:...
Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to...