Danish guidelines on "tailor-made" devices now available
This article was originally published in Clinica
Executive Summary
The Danish Medicines Agency (Laegemiddelstyrelsen) last week published guidance for on "tailor-made" medical devices. The guidance is based on an announcement from the ministry for health and internal affairs on May 27 2003 and aims to ensure that existing laws are correctly applied.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.