FDA 10 Guiding Principles of Good AI Practice in Drug Development
Get to know the FDA 10 Guiding Principles of Good AI Practice in Drug Development and what they mean for AI governance, validation, and regulatory risk.
FDA Master Protocol Guidance for Smarter Clinical Trials
Explore the FDA's Master Protocol guidance and how basket, umbrella, and platform trials can improve clinical trial efficiency, especially in oncology and biologics.
One Pivotal Trial for FDA Approval? Success Depends on Trial Design
One pivotal trial for FDA approval could accelerate drug development, reshape clinical trial strategy, and change the pharmaceutical regulatory landscape.
FAST-EU Pilot: Can Europe Finally Accelerate Multinational Clinical Trials?
The FAST-EU Pilot aims to accelerate multinational clinical trials through faster coordinated assessments, supporting Europe’s 2030 clinical research ambitions.
FDA Oncology Trial Guidance Targets Eligibility Barriers
FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.
What Sponsors Need to Know About UK Combined Review 2026
UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.