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?
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: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health...
Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines,...
Cancer, COVID-19, Continuity
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
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
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 FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient
This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance to meet Prescription...
New FDA Guidance on Natural History Studies for Rare Diseases
In a recent blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in...
Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?
By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist On March 5, the FDA approved Spravato...