Articles tagged with “regulatory-science”

ICH M15 Guideline Explained: MIDD Framework for 2026

A 2026 analyst guide to the ICH M15 model-informed drug development guideline: the six-element risk framework, FDA and EMA timelines, MAP/MAR requirements, and five real case studies.

40 min read

7/2/2026

ich m15 model-informed drug development midd pharmacometrics fda midd guidance regulatory science pbpk modeling drug development guideline ich guidelines 2026

FDA ISTAND Program: AI Drug Development Tool Qualification

An educational guide to the FDA ISTAND program, explaining the DDT qualification process and the regulatory integration of AI-based drug development tools.

35 min read

7/2/2026

fda istand drug development tools ddt qualification regulatory science ai drug development clinical outcome assessment digital health technology

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