REGULATORY
PMDA Considering Review Procedure Policy for IVD Agents Based on FDA Guidance Draft
Regarding ongoing requirements to enhance the review system for in vitro diagnostic (IVD) agents aimed at promoting personalized healthcare, Pharmaceuticals and Medical Devices Agency (PMDA) Deputy Review Director Daisei Miyamoto (Office of Medical Devices II) revealed at a lecture held…
To read the full story
REGULATORY
- OTC-Like Drugs Left in Limbo as Panel Debates Cost-Sharing without Clear Policy Signal
December 19, 2025
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
- Japan Moves LLP Payment Hike toward Political Call, Eyes 1/2 or Higher
December 18, 2025
- Panel to Weigh Orphan Designation for Tecartus on December 22
December 17, 2025
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
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…





