More Resources Sought For Using Patient-Preference Data In US Device Reviews
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration's vision for the next Medical Device User Fee Act is to ensure the reliability and sustainability of the device review program, but it is also considering 'other components' not traditionally considered, such as how to get resources to include patient preferences in decision-making, the agency said in minutes of a recent MDUFA IV patient/consumer stakeholder meeting1.
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.