Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available
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
I think the post approval page is an excellent addition to the FDA website. I have reviewed it and look forward to accessing it.
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Useful blog and goo sharing,keep it on good way. Happy new year all good stuff.
This is a great step towards transparency and making the consumer of medical devices more educated. I hope this webpage will be used by health care professionals to provide the best care to their patients.
yah your right i like it
Im glad that the public has access to this information as well. Keep up the good work!
Yeah i think its a very good idea creating an approval page for each study.
look forward to your next post after January.
Wow, this is really smart. Also – It will become easier with Health Information Exchanges to identify patients using the devices, if there’s a post-approval recall.
Wow, this is really smart. Also – It will become easier with Health Information Exchanges to identify patients using the devices, if there’s a post-approval recall.
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Yeah i think its a very good idea creating an approval page for each study.Nice blog, im already shared this page to my friend
I think this is a good idea creating an approval page for each study and
is a great step towards transparency and making the consumer of medical devices more educated. I hope this page will be used by health care professionals to provide the best care to their patients.
It is a fantastic stage toward visibility and also creating the buyer regarding health-related gadgets a lot more knowledgeable. I am hoping this kind of website will probably be employed by medical care specialists to offer the most effective attention with their individuals.
Im glad that the public has access to this information as well. Keep up the good work!
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