European Commission To Allow Pre-MDD Non-CE Mark Devices Until 2001
This article was originally published in The Gray Sheet
Recommendations concerning the use of non-CE marked devices after June 14 in member states have recently been upgraded to a "communication" by the European Commission, Smith & Nephew Director of European Regulatory Affairs Ian Cutler told attendees of a European device conference June 25 in Washington, D.C.
You may also be interested in...
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
However, Vaccinex sees possible efficacy for SEMA4D inhibition in later-stage Huntington’s as well as Alzheimer’s disease. Pepinemab is also being studied with Keytruda in head-and-neck cancer.
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.