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.”
New Sources Changing the Meaning of Evidence?
AI Research Can Optimize Clinical/Operational Effectiveness
Has Joining ICH Accelerated Innovation in China?
Pricing Pitfalls in Prescription Drug Advertising
MID-NET Among PMDA’s First Steps Into RWE
Regulatory Science 2019: Leading or Holding Back Innovation?
23andMe: Information Empowering Patient Action
The Patient’s Most Engaging Question: Why?
EUnetHTA: Post-Launch Critical for Comparative Data
HSA Harmonizing Culture and Science in Singapore
Promoting Patient-Centric Business: MedComm in Latin America
Separate but Equal: Regulatory & Pricing Assessments in EU
Genetics Leading Modern Revolution in Cancer Care
Automation No Substitute for Scientific Leadership
R2D2 & C-17 New Landmarks in Canada’s Collaborative Pathways
Advanced Therapies Moving Upon Combination Platforms
Challenges in Generic Drug Safety & Surveillance
Interview with a DIA 2018 Patient Scholar
Novel Approaches to PV Collaboration
Advancing the Science of Study Endpoints
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