For many organizations the Internet has provided an avenue for transparency. The FDA for example, according to FDANews and Drug Industry Daily, is planning to post adverse event evaluations online. The adverse event information will be updated on a quarterly basis and will include summary analyses. Related literature and sources will also be published.
According to FDANews, the focus of the project will be to identify new, potential or known risks that are observed in unusual quantities. FDANews also notes that, "if a new issue is revealed, it will undergo a formal safety review to characterize the safety signal and determine if any regulatory action is warranted and what additional clinical information is necessary."
The benefits of increased the increased transparency of essential life science related information are obvious. The information will provide trends and information that will help lead to continuous improvement.
To view more information, please visit the FDA News website.
|Download Free Resources|