Japan Ministry Says Kanebo Ignored Law Requiring Side-Effects Reports
This article was originally published in PharmAsia News
Executive Summary
Kanebo Cosmetics, which makes medicine-based products that bring them under drug-regulation authority, apparently ignored a health ministry order in 2011 to report adverse side effects.
You may also be interested in...
Rejection Rate Soars In Q4 For EU Fast-Track Requests
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Biden Regulatory Freeze May Pause SUNSET Rule
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
Canada Boosts Postmarket Device Safety With New Reporting Rules
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.
Need a specific report? 1000+ reports available
Buy Reports