It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.
One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.
In this audio conference, you will learn the latest information on registration of medical device trials and what you must do for compliance.
Registering Device Trials on ClinicalTrials.gov was presented by Amy Wise, Manager of Clinical Research, with PharmaNet and aired on 2008-11-13. For more details, or to download this event please visit our site at www.fxconferences.com
