Archive for December, 2010

Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available

December 22, 2010 17 comments

FDA is taking steps to improve transparency about studies conducted with devices after approval.   The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications.  The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner.

CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study.   The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods.  For completed studies, you can find information about final study results, safety and effectiveness findings, strengths and weaknesses of the study, and recommended labeling changes, if any. 

This post will be last one until January 2011.  Happy holidays to all of our readers and best wishes for the New Year!

Afia Asamoah, Transparency Initiative Coordinator

Monthly Visitor and Rating Statistics Now Available on FDA Basics

December 15, 2010 12 comments

FDA Basics is the agency’s web-based resource that provides basic information to the public about FDA and the work of the agency (see January 12 blog post).  Now available on FDA Basics are summary statistics about the number of visitors coming to the site each month, the number of comments submitted by the public each month,  as well as the average rating (based on a 5 point scale) for the content on FDA Basics.    The statistics will be updated monthly and are available here.

Let us know what you think of the new metrics page on FDA Basics.  And continue to check out the content on FDA Basics.  You can suggest additional questions and rank how useful you found the answers we provided.   New content is added on a regular basis (see the “What’s New” tab on the FDA Basics homepage).

Afia Asamoah, Transparency Initiative Coordinator


Materials Available from FDA Basics Webinar on Melamine: The Cause of the Pet Food and Infant Formula Recalls

December 9, 2010 11 comments

Did you miss the FDA Basics webinar on how FDA uncovered and confirmed the presence of contaminants in the 2007 pet food recalls?

Materials from the webinar are now available on the FDA Basics website.

Check out the “What’s New” box on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides.

You can find materials from past FDA Basics webinars here.

Afia Asamoah, Transparency Initiative Coordinator

New Updates on FDA-TRACK, Agency’s Performance Management System

December 6, 2010 8 comments

FDA’s performance management system, FDA-TRACK, allows the public to track the agency’s progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post).

New performance data is now available on FDA-TRACK.  Check out FDA-TRACK for updates from November 2010, including updates on the number of Freedom of Information Act (FOIA) requests processed in FY 2010 and the agency’s progress filling vacancies on FDA advisory committees.

Afia Asamoah, Transparency Initiative Coordinator

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