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

IT Fix Underway, Says FDA Commissioner; More Funds Needed, Say Critics

This article was originally published in The Gray Sheet

Executive Summary

In a contentious congressional hearing Jan. 29, FDA Commissioner Andrew von Eschenbach conceded that FDA's flawed information technology infrastructure impedes the agency's ability to monitor device and drug safety, but refused to say how much money would be needed to improve the IT systems

You may also be interested in...



Regulatory News In Brief

FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)

Regulatory News In Brief

FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)

Bush Budget Request Would Cut 10 Staff Positions At FDA Device Center

President Bush's Feb. 4 budget request asks for about $7 million in additional funds for FDA's device program in fiscal year 2009 compared to current levels, but would cut 10 full-time staff equivalents at CDRH

UsernamePublicRestriction

Register

OM007016

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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