US FDA to hold workshop on nanomaterial-containing devices
This article was originally published in RAJ Devices
The US Food and Drug Administration plans to hold a public workshop on 23 September to gather information on the manufacturing, characterisation and biocompatibility evaluation of medical devices and diagnostics that contain or use nanomaterials and nanostructures1.
You may also be interested in...
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.
The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these.
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.