FDA Policy/General

Workshop on National Device Evaluation System

Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 3/24 entitled “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.” Its objective is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The workshop will be held from 8:30 a.m. to 4:30 p.m. at the University of Maryland, Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. Contact Ann Anonsen, University of Maryland, (301) 405-0285. To view this notice, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome