B Braun withdraws dura mater product
This article was originally published in Clinica
Executive Summary
German healthcare company B Braun Melsungen has voluntarily withdrawn all Lyodura dura mater implants worldwide, produced before January 1996, because it cannot trace the origin of all products. An inability to trace raw material in all cases contravenes good manufacturing practice standards, admitted head of marketing Gerhard Meil. He claimed that the origin of most tissue used in Lyodura can be traced.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.