Good Clinical Practice (GCP), the bedrock of ethical and ... However, like other aspects of drug development, it is evolving. The International Council for Harmonisation of Technical Requirements ...
By the end of 2024, the US Food and Drug Administration ... requiring sIRB review. It’s good news for everyone, even if it represents a shift in control from clinical trial sites to the industry ...
Novavax’s shares jumped in pre-market trading on the news but settled once markets opened. Less than a month after putting Novavax’s investigational combo COVID-19/influenza and standalone influenza ...
The trial is managed by ComboTrial Consultancy Ltd. under Good Clinical Practice standards. Following the IRB approval from Shuang Ho Hospital, Ainos plans to submit to Taiwan’s Food and Drug ...