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."
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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