DIA: Driving Insights to Action
Science:Life Sciences
In 2018, the US FDA approved a record high number–59–of new, novel drugs. “We are at a point now where there is so much innovation in this space and the regulatory aspects are catching up, so we now have three approved gene therapy products in the US and over seven to eight hundred INDs for cell and gene therapy filed with FDA,” explains Dr. Adora Ndu, Executive Director of Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical, and Regulatory Science Co-Editor for DIA Global Forum. “With each interaction with each product that’s filed and with each product that’s approved, the regulatory experience is broadened.”
Complexity Continues to Challenge Clinical Costs
Maximizing Regulatory Resources Across Latin America
Data Intersections Connecting Drug Development with Clinical Care
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2
Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1
Advanced Tests and Therapies Making Daily Care Anything But Routine
Innovation Without Access Will Never Meet Patient Needs
Three Good Reasons to Use Artificial Intelligence in Pharmacovigilance
EU Regulatory Strategies Shaping and Shaped by Pandemic Response
Telehealth Emerging in Japan’s Clinical Research and Care
Aligned Review Timelines Key to Co-Developing Companion Diagnostics
Early Access Programs Complicating Comparative Data Analyses
New PAHO Report: Strength in Regulatory Reference and Reliance
eLabeling More than Moving from Paper to Digital
RIM Whitepaper V2 and RIM Reference Model: Advancing Regulatory Science
Australia: Growing Clinical Trials Even in Pandemic’s Wake
Remote Tools Keep Japan's Research Moving
DIA Promoting Community, Pushing Back Misinformation
Japan Healthcare 2035: Focus on Basic Science & Economics
DARWIN EU: Evolution in Europe’s Use of Big Data
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