DIA: Driving Insights to Action
Science:Life Sciences
“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making. In this research article, Miller (Forum for Collaborative Research) and Adora Ndu (Bridgebio Pharma, Inc.) describe where and how FDA has used external controls to support development and approval of drugs for rare and pediatric diseases. “We're seeing, not just in rare diseases but in many other diseases, this coming together of what used to be totally separate silos. In part, that's facilitated through electronic health records and other mechanisms of capturing data and being able to follow data at a bigger level, but also just because of understanding the importance of clinical data.”
Patient-Focused Drug Development: What Must We Still Do?
Interchangeable Biosimilars: A Global Perspective
Game Technology Opens New Path to Clinical Endpoints
Challenges and Opportunities for South Africa’s New Regulatory System
Clinical, Data, and Quantitative Science Now Converging
Realizing the Full Potential of CRISPR: Is the Hype Getting in the Way of Progress?
Tackling Ethical Questions in Clinical Research and Drug Development
WHO 2030 Framework for Efficient, Effective Regulation
AI: Opportunity for More Informed Drug Development Decisions
Clinical Training Critical in China’s Cancer Fight
Changing Research in China: From Generics to Innovators
Running Away from Addiction Has Caught Up with US
Has the Time for Big/Real World Data Finally Arrived?
Will AI Make Workers More (or Less) Valuable?
PvPI: Technology Meets Opportunity to Improve Safety
New EU CTR: One Application, One Portal, One Decision
US Generic Drug Policy: Less Cost, Same Impact
Multiple Pathways Complicate Opioid Pain Management
Breakthrough for Patients & Regulatory Science
DIA 2018 Co-Chair: Patient Activists Are “Our Best Friends”
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