US FDA Eyes March For Submission Tracker Pilot Launch
Executive Summary
The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.
You may also be interested in...
Sign-Ups Open For US FDA Premarket Progress Tracker Pilot
The pilot will allow at least a hundred device companies with 510(k)s under review this spring to test out the new industry submission-tracking dashboard.
FDA To Launch Web-Based Premarket Tracking Program In January
As part of its MDUFA IV commitments, the US agency will launch a pilot program that will streamline how sponsors can track their premarket applications online.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.