February 18, 2019
  • Patients Are Eager for Trials But Aren’t Getting the Word, Survey Finds
  • Drug Industry Comments on FDA’s Real-World Evidence Program

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February 11, 2019
  • CDER Drug Trials Report Shows Declining Enrollment
  • Keep Investigator’s Brochure Updates Clear, Concise and Timely, Experts Advise

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February 4, 2019

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January 28, 2019
  • Investigators Most Likely to Be Cited for Failing to Follow Protocols, FDA Records Show
  • FDA Back to Work; Gottlieb Announces New Clinical Trial Plan

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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  • FDA Addresses Rare Disease Trial Challenges in Revised Draft Guidance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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