CDRH stakeholders meeting
This article was originally published in The Gray Sheet
Executive Summary
FDA Associate Commissioner for Strategic Management Linda Suydam and CDRH Director Bruce Burlington are members of an agency panel that will convene at an Aug. 18 public meeting on Sec. 406(b) of the FDA Modernization Act. The meeting, which is mandated under FDAMA, will be divided into three sections, including: Medical Device Users (Part One) and Health Organizations; Trade Associations/Standards Organizations; and Medical Device Users (Part Two) and Patients and Consumers. The meeting begins at 9:00 a.m. in the HHS Humphrey Building in Washington, D.C. FDA will hold a second public meeting on the issue on Sept. 14. For further information, contact Catherine Beck at 301/827-3443
You may also be interested in...
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.
Merck’s Winrevair Well Positioned To Benefit From Medicare Part D Redesign
Significant cost sharing reductions under the redesign will enhance uptake of the pulmonary arterial hypertension drug. The trade-off is a 20% mandatory price discount in the catastrophic phase.