Current Regulatory Guidance & Insights

Since the emergence of COVID-19 in the US, the FDA has released new guidance and information rapidly and continuously in a comprehensive response to the current pandemic. The guidance provides recommendations for conducting research, both for new and ongoing programs, during this complex research landscape. Our experts provide insights on the guidance and recommendations for best practices for conducting research during this pandemic.

COVID-19 FDA Response: Guidance Released for Conduct of Ongoing Trials

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Development of COVID-19 Therapies: FDA Pathways

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Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD

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COVID-19 FDA Response: Guidance on Protocol Amendments and Clinical Study Reports in Affected Ongoing Trials

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COVID-19 FDA Response: Site Management and Monitoring

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Changes to Study Visits and Assessments During COVID-19: Subject Safety Considerations

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Drug Shortages During the COVID-19 Pandemic

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Maintaining Trial Integrity During COVID-19: Some Statistical Rules of Thumb

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