Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Web-based portal may improve quality of adverse event reports

This article was originally published in The Silver Sheet

Executive Summary

FDA and the National Institutes of Health have entered into a memorandum of understanding that aims to deliver a centralized Web-based portal for adverse event reporting that may improve report quality, lower costs and reduce delivery time. Both agencies already are working on their own revamped adverse event reporting systems. FDA has its long-term sights on a single, agency-wide electronic portal - dubbed MedWatch Plus - for collecting adverse events, consumer complaints and other information relating to all products it regulates. NIH has created the Federal Adverse Event Task Force (of which FDA is a part) to develop a portal designed so clinical trial adverse events can be reported in a single, standardized format. With the MOU, the agencies are combining efforts. "NIH and FDA aim to develop a project that will result in a Web-based method for consumers, health professionals, investigators, sponsors and other parties to electronically submit [adverse event] reports," the memorandum states
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036190

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel