Audit Takes Health Canada To Task On Device Marking, Review Performance
This article was originally published in The Gray Sheet
Executive Summary
Canadian medical device trade organization Medec will oppose the Office of the Auditor General's proposal to mark devices licensed by Health Canada
You may also be interested in...
International Memoranda Of Understanding To Bridge Regulatory Divide – FDA
FDA will develop additional Memoranda of Understanding this year, based on other nations' increased product trade with the U.S. and FDA's ability to leverage resources with various regulatory agencies
Parkinson’s Results Further Sweeten AbbVie’s Acquisition of Cerevel
Cerevel, which AbbVie is spending $8.7bn to acquire, unveiled topline results from the TEMPO-3 study of tavapadon, which an analyst said represents potentially a $1bn opportunity.
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.