Good clinical practices: FDA opens updated ICH draft guidance for comments
The FDA this week released new draft guidance that aims to modernize clinical trials, with an update to the International Council for Harmonisation’s (ICH) overarching Good Clinical Practice (GCP) guidance, last updated in 2016.
GCPs are the internationally-recognized ethical, scientific and quality standards that human trials should adhere to, making any updates to the ICH guidance closely watched. In this latest round of reforms, the guidance offers new recommendations applicable to a broad range of trials including those with innovative design elements or digital health technologies.
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