International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
New ISO standard for symbols: A new standard from the International Organization for Standardization offers a methodology for developing and presenting symbols related to medical devices that can be understood independently of language to "avoid the confusion that users may experience when presented with labeling in different languages," ISO said March 24. Manufacturers and regulators can also use the standard, ISO 15223-2:2010, for validating symbols "where suitable symbols are not standardized," the organization notes. Among other specifics, the standard provides test methodology and acceptance criteria to help ensure that a candidate symbol is suitable for adoption and use, according to ISO
You may also be interested in...
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.