New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings
Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended...
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
Special Interest Guidances/Information Date Posted Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30...
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...