REGULATORY
Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
Japanese regulators should immediately green-light the pediatric use of 16 cancer drugs approved for adults in Japan that carry indications for children in the US as a special measure that goes beyond the existing laws and regulations, a clinical oncologist…
To read the full story
Related Article
- MHLW to Clarify Criteria for Japanese PI Waivers through Q&A, Calls for Data-Based Justifications
October 14, 2025
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
- PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
July 10, 2025
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- Japanese PI Waiver Good News to Mega Pharma and Emerging Players Alike: Pfizer Execs
January 21, 2025
- Japan Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
REGULATORY
- 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
- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
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…





