Mandated label changes?
This article was originally published in The Tan Sheet
Executive Summary
"For me, the FDA has to be given the ability to mandate labeling changes after approval," GlaxoSmithKline Senior VP-Worldwide Development Ronald Krall stated at the meeting. "After appropriate consultation, including experts in the field and the company, FDA needs to be able to say 'enough is enough, here's the labeling.' We don't need this because FDA needs a hammer, but because the public is uncomfortable with how long it takes us to communicate information about our products"...
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.