FDA Should Turn Over AE Analysis Criteria To Firms – Boston Scientific Exec
This article was originally published in The Gray Sheet
Executive Summary
Much of the analysis of device-related adverse event reports currently handled by FDA could be completed by device manufacturers if the agency provided the criteria, according to Boston Scientific Manager for Quality and Regulatory Compliance Kristin Johnson
You may also be interested in...
Feigal, Tunis To Present At HHS Reg Reform Panel On FDA/CMS Partnerships
Collaborative opportunities between FDA and the Centers for Medicare & Medicare Services for approving new technologies will be explored during the upcoming 1HHS Advisory Committee on Regulatory Reform's public hearing in Minneapolis
CDRH To Start New Year By Expanding Alternative Summary Reporting
Malfunction reports for ventilators and surgical staplers will be eligible for alternative summary reporting (ASR) in early 2001, FDA Center for Devices and Radiological Health officials predict.
Sandoz Denosumab Biosimilar Progressing Faster Than Anticipated
Sandoz announced more than a year ago that its GP2411 biosimilar denosumab candidate had entered the clinic. Management provided an update on its progress at the recent Virtual Meet Novartis Management Investor Event.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: