DIA: Driving Insights to Action
Science:Life Sciences
In late March 2020, FDA issued Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: Guidance for industry investigators and institutional review boards. In the agency statement accompanying its release, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah stated, "FDA released this guidance to emphasize that at all times patient safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants."
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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