FDA panel dispute date set for CardioGenesis:
This article was originally published in Clinica
Executive Summary
An independent panel from the US FDA is scheduled to meet on August 20 to help settle a dispute over CardioGenesis' application to market its percutaneous heart laser treatment for angina. The medical devices dispute resolution panel consists of a body of experts authorised to mediate scientific disputes between an applicant and the FDA. It will review and make recommendations concerning the agency's decision to reject the Foothill Ranch, California firm's premarket approval application last year (see Clinica No 1047, p 21). Its recommendation will be made to director of the FDA's Center for Devices and Radiological Health. CardioGenesis is only the second firm to make use of the panel. LifeCore Biomedical was the first in 2001 (see Clinica No 974, p 9).
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.