J&J GATHERING STRESS, BENESTENT TRIAL DATA FOR FDA SUBMISSION
This article was originally published in The Gray Sheet
Executive Summary
J&J GATHERING STRESS, BENESTENT TRIAL DATA FOR FDA SUBMISSION in support of its premarket approval application for the Palmaz- Schatz coronary stent. In December, FDA's circulatory system devices panel recommended against approval of the stent due to the inadequacy of Johnson & Johnson Interventional Systems' nonrandomized clinical trial ("The Gray Sheet" Dec. 20, 1993, p. 3). However, the panel suggested that the Stent Restenosis Study (STRESS) and the Benestent trial might provide sufficient data for approval.
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.