REGULATORY
Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
Japan has started weighing the introduction of a withdrawal rule for its conditional approval system, which grants regulatory clearance with strings attached when PIII confirmatory trials are not feasible due to small patient populations or other such reasons. The Ministry…
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Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…





