Sep 23, 2009
The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.
By mid December, the transcript for the meeting will be available under the Division of Dockets Management, available online. Issues that will be discussed include the distinction between when a product is being promoted and when it is being advertised, and the reporting of adverse event data. Further, how often and to what extent companies, consumers, and health care professionals use social media (Twitter, Facebook, wikis, blogs, video sharing, etc) to promote topics of public health and how they are impacted by such promotion will also be examined. The following discussion questions are a sample of those that will be posed at the public hearing. For more information, visit the official notice in the Federal Register
You can submit your comments online on https://www.regulations.gov/. When you are on the site, use docket No. FDA-2009-N-0441 to identify your comment.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
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