Articles tagged with “regulatory-science”

Project Orbis: Oncology Drug Review & Global Expansion

Explore Project Orbis, the FDA's global oncology review framework. Analyze approval timelines, partner agencies, and challenges in expanding beyond cancer.

30 min read

2/28/2026

project orbis fda oncology regulatory affairs drug approval process global harmonization concurrent submission clinical trials regulatory science

Real-World Evidence: A Guide to RWE Analysis & Application

Explore the state of Real-World Evidence (RWE) analysis in 2025-2026. This guide covers RWD sources, analytical methods, FDA/EMA regulatory frameworks, ICH E6(R3), synthetic control arms, AI-driven RWE platforms, and compares RWE with RCTs

40 min read

11/16/2025

real-world evidence real-world data pharmacoepidemiology rwe vs rct regulatory science drug development ehr data health outcomes research