Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out ...

The International Council for Harmonisation (ICH) has released its highly anticipated draft guideline that harmonizes principles for the design, analysis, and reporting of adaptive clinical trials in ...

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...