EU Clinical Trial Regulation: What, When, Who, Why, How?

juin 15, 2021

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review...


Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider

mars 25, 2021

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have rigorous processes for reviewing applications for...


EMA & FDA Approvals and Recommendations in 2020 for Oncology Drugs and Diagnostics/Devices

janvier 18, 2021

Similar to previous years, 2020 also proved overall to be a successful year for drug approvals despite the COVID-19 pandemic....