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