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FDA draft clinical trial guidance promotes decentralized studies, digital tech use - GCP guidance comes ahead of FDA DCT webinar | Hogan Lovells

FDA draft clinical trial guidance promotes decentralized studies, digital tech use - GCP guidance comes ahead of FDA DCT webinar | Hogan Lovells
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Robertm califfHogan lovellsDigital health technologyGood clinical practiceIntegrated addendumGeneral considerationsClinical studiesHealth technologyClinical trial

FDA announces additional steps to modernize clinical trials

The US Food and Drug Administration (FDA) has announced this month (June) it is requesting feedback on draft recommendations and how they should be applied to increasingly diverse trial types and data sources.

Robert califfKhair elzarradExpert working groupInternational council for harmonisationInternational councilWorking groupGood clinical practiceIntegrated addendum

FDA Announces Additional Steps to Modernize Clinical Trials to Diversify Trial Types and Data Sources

The FDA has announced it is taking additional steps to modernize clinical trials, and is requesting feedback on draft recommendations, and how they should be applied to increasingly diverse trial types and data sources, according to a June 6 news release issued by the agency.

Robertm califfM khair elzarradInternational council for harmonisationExpert working groupDrug administrationResearch office of medicalInternational councilDrug evaluationWorking groupGood clinical practiceIntegrated addendum

FDA Announces Additional Steps to Modernize Clinical Trials to Diversify Trial Types and Data Sources

FDA Announces Additional Steps to Modernize Clinical Trials to Diversify Trial Types and Data Sources
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M khair elzarradRobertm califfResearch office of medicalDrug administrationExpert working groupInternational council for harmonisationInternational councilDrug evaluationWorking groupGood clinical practiceIntegrated addendum

FDA Announces Additional Steps to Modernize Clinical Trials

The FDA is announcing the availability of a draft guidance with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials.

Robertm califfM khair elzarradResearch office of medicalUs department of healthInternational council for harmonisationHuman servicesExpert working groupDrug administrationFor immediate releaseInternational councilDrug evaluationWorking groupGood clinical practiceIntegrated addendum