Unresolved issues mean that debate on the IVD (In Vitro Diagnostics) Directive will continue for some time to come
This article was originally published in Clinica
Executive Summary
The grey areas of the In Vitro Diagnostics Directive (IVDD) will need to be resolved, probably by means of guidelines in the form of "Meddev" documents from the European Commission, according to Maurizio Suppo, principal consultant with MTC-Quintiles. However, in the meantime manufacturers should decide which private testing and certification companies they will use for CE marking under the directive and liaise with them as soon as possible on how these areas should be interpreted.
You may also be interested in...
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.