Blog

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...

Blog

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....

Blog

Clinical Highlights from the First Virtual European Society for Medical Oncology Congress

décembre 11, 2020

This year’s ESMO Annual Scientific Meeting took place between 19th-21st of September, with the Educational Program occurring during the 16th-18th...

Blog

Strategizing for NDA/BLA Series Part 2: Planning Ahead for Your NDA or BLA

décembre 9, 2020

This blog is the second part in our “Strategizing for NDA\BLA” series. The first part can be found HERE –...

Blog

Current and Emerging Therapies for Patients With Multiple Myeloma

novembre 5, 2020

Multiple myeloma (MM) is a malignant disease of the bone marrow characterized by clonal expansion of plasma cells (1, 2)....

Blog

Improving Informed Consent in Clinical Trials

octobre 16, 2020

Does more information mean better knowledge? Authors: Ruth Cohen PhD, Regulatory Affairs Associate, CATO SMS Recruitment and retainment of patients...

Blog

New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

octobre 5, 2020

By Sheila Plant, PhD, RAC, Senior Director, Regulatory Affairs at CATO SMS  Special Interest Guidances/Information Date Posted Providing Regulatory Submissions...

Blog

New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

septembre 3, 2020

By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS  Special Interest Guidances/Information Date Posted Principles for Selecting,...

Blog

New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings

août 5, 2020

By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Pediatric Study Plans:...

Blog

Immuno-oncology updates in the virtual era – ASCO 2020

juillet 27, 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...