Latest News | 5 December 2012

CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

It’s that time of year—the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no Read More...

Latest News | 2 October 2012

Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA

The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly Read More...

Latest News | 20 August 2012

Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared Read More...

Latest News | 7 August 2012

Report: Monitoring Scandal Involves Top FDA Officials

Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports Read More...

Latest News | 16 July 2012

Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of Read More...

Latest News | 23 April 2012

Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval Read More...

Latest News | 19 April 2012

Drafts of PDUFA, MDUFA Released in House, Senate

Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Read More...

Latest News | 10 April 2012

FDA Opens Innovation Pathway to First Round of Devices

The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease Read More...

Latest News | 30 March 2012

Shuren's Senate Testimony Yields Wealth of Insight

The US Food and Drug Administration’s (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education, Read More...

Latest News | 28 March 2012

Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012A Senate hearing is scheduled to hear testimony Thursday(29 Read More...

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