January 21, 2018
  • FDA Addresses Rare Disease Trial Challenges in Revised Draft Guidance
  • Centralized Monitoring in Practice — Lessons Learned from Early Implementers

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January 14, 2019
  • FDA Commissioner Warns of Shutdown’s Impact on Clinical Trials
  • Establishing Indemnification in a Clinical Trial Agreement Requires Precise Language

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January 7, 2019
  • Time to Rethink the Business Model, Exec Warns After ‘Disheartening’ R&D Report
  • Genetic Counselors Help Researchers Prepare for the Coming Wave of CNS Disorders

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December 31, 2018
  • FDA Challenges Sponsors to Create New Approaches to Patient Experience Data
  • Interview: Challenges and Opportunities in Psychiatric Trials

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December 17, 2018
  • FDA Lays Out Qualification Path for Biomarkers in Clinical Trials
  • Debarment Certification: A Must-Have in Any Clinical Trial Agreement

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December 10, 2018
  • FDA on Real-World Evidence: Let’s Keep Talking
  • FDA: New Approaches for Fatty Liver Clinical Trials

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December 3, 2018
  • New Training Standards Sought for PIs
  • FDA Wants to Modernize 510(k) Trials

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November 19, 2018
  • Complex Data Need Simplified Trials, Expert Argues
  • FDA Trials Inspection Algorithm: Be Ready

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November 12, 2108
  • FDA Draft Guidance on Clinical Trial Meta-Analyses
  • UK: Refocus Cancer Trials to Consider Quality of Life

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November 5, 2018
  • Are Clinical Trials Headed for Tech Disruption?
  • Legislative Efforts to Pay Trial Participants Pay Off

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