German law changes will upgrade surveillance & "seal the cracks"
This article was originally published in Clinica
Executive Summary
Changes to Germany's medical product law, the Medizinproduktegesetz (MPG) coming up in January 2002 will "seal any cracks in the existing regulations". That is the confident view of Hans Georg Will, director of the medical devices department at the ministry of health. Speaking at a special MPG transposition conference last week held by the medical device industry association (BVMed), he said the new law - the second amendment of the MPG - was better targeted and clearer than existing legislation. It will also transpose the two most recent European directives on in vitro diagnostics (IVDs) and medical devices, which incorporated derivatives from human blood or plasma.
You may also be interested in...
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.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.