FDA Commissioner Robert Califf has called for major reform of the clinical research enterprise, particularly in how clinical evidence is gathered, to reduce health disparities between scientific advancement and actual U.S. life expectancy, a huge undertaking that some clinical trial experts question.
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The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication GCP Questions, FDA Answers.
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Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers.
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The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations.
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With this year’s WCG MAGI East conference in Philadelphia just a few months away, WCG is now calling for site, sponsor and CRO representatives to submit innovative approaches from their organizations for its Innovation Challenge competition.
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