"SAFETY ONLY" DEVICE EVALUATION INCONSISTENT WITH COST- CONTAINMENT
This article was originally published in The Gray Sheet
Executive Summary"SAFETY ONLY" DEVICE EVALUATION INCONSISTENT WITH COST- CONTAINMENT trends in the medical care industry, FDA says in a recent background document responding to calls for the Center for Devices and Radiological Health to regulate only the safety, and not the effectiveness, of medical devices. "In an era of increasing emphasis on cost-containment," FDA contends, a "safety only" device evaluation system "would waste money by subjecting patients to ineffective treatments before the 'medical marketplace' weeded them out." FDA released the backgrounder in response to an Aug. 12 report on the ABC News television program "20/20" that was highly critical of CDRH's approval policies.
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.