Clinical Highlights from the First Virtual European Society for Medical Oncology Congress
This year’s ESMO Annual Scientific Meeting took place between 19th-21st of September, with the Educational Program occurring during the 16th-18th...
Strategizing for NDA/BLA Series Part 2: Planning Ahead for Your NDA or BLA
This blog is the second part in our “Strategizing for NDA\BLA” series. The first part can be found HERE –...
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 Selecting,...
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...