CDRH ready for eMDR testing
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center announces it is ready to start testing electronic submissions of medical device reports under its eMDR program. In the works for several years, the program aims to improve the center's ability to detect more critical adverse event reports among the more than 200,000 adverse event submissions it receives annually. Most of the submissions currently are sent in by fax, and must be typed in manually by data entry contractors. The project is one component of the center's expansive postmarket "transformation" initiative (1"The Gray Sheet" Feb. 20, 2006, p. 12). CDRH is accepting eMDR submissions from anyone who would like to participate. The program eventually will be mandatory as FDA moves to go completely electronic...
You may also be interested in...
CDRH Tries To Move Adverse Events Into Electronic Age With eMDR Pilot
CDRH will take its first tentative steps towards electronic medical device reporting (eMDR) with a pilot program scheduled to launch this summer
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.