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…
REGULATORY
Panel Discusses Potential Waiver of Japanese Trials for Ultra-Orphan Medicines
A health ministry panel on pharmaceutical regulations on December 13 discussed the need for confirmatory trial data in Japanese subjects for drugs to treat ultra-rare diseases. The industry proposed waving the implementation of Japanese studies when deemed appropriate in a…
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