FDA Clarifies PMA Filing Procedures In Latest MDUFMA Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA's May 1Premarket Approval Filing Review guidance, which provides criteria and examples for staff on when to accept or reject a PMA for filing, solicits stakeholder comments on their experiences with the device center's filing process
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.