EU Clinical Trial Regulation: What, When, Who, Why, How?
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
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
Similar to previous years, 2020 also proved overall to be a successful year for drug approvals despite the COVID-19 pandemic....
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? Recruitment and retainment of patients for clinical trials can be a major challenge, especially...
New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings
Special Interest Guidances/Information Date Posted Providing Regulatory Submissions in Electronic Format — Standardized Study Data 29 October 2020 Nonclinical Testing...
New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings
Special Interest Guidances/Information Date Posted Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device...
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...