Danish authorities tighten requirements for devices:
This article was originally published in Clinica
Executive Summary
Danish regulatory authorities have notified the European Commission that they intend to introduce a new technical specification for ultra low-power active implantable medical devices. The requirement concerns electromagnetic compatibility and demands that equipment be set between the frequency of 402-404MHz. The European Commission and other member states have until March 29 to comment on the proposal.
You may also be interested in...
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.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.