Topic

Articles

Roadmap of twists and turns that lie ahead following most recent draft issued in September.

Faculty, Program Coordinator, Senior Lecturer, MS in Regulatory Science & Food Safety Regulation Programs, Johns Hopkins University

Lessons learned from FDA’s current process and proposed alternative review strategies.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Increased public engagement leads recent change in EMA profile.

Lessons learned from COVID-19 vaccine development.

Kenneth Getz is a senior research fellow at the Tufts Center for the Study of Drug Development.

Improving receptivity and response to the evolving nature of clinical trial patient oversight.

Implementing new strategies with the use of patient-reported outcomes.

Higher costs headline list of new challenges faced by CROs and sponsors.

The data, not the plan, provide the direction. 

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.

FDA emphasizes importance of inclusion in trials.