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FDA Official States Need for Greater Data from Public Stakeholders and Industry to Inform the Guidance Process for use of Internet and Social Media in the Promotion of FDA-regulated Medical Products
Date:2/9/2010

is date.  This news is particularly important to companies that are in the process of planning or currently conducting research but might not have it completed or analyzed in time.  In such cases, she recommends that companies provide the FDA with some kind of advanced notice that they are planning on submitting late.  Submitting an outline or abstract of the research could also prove useful.  

"I believe the FDA is truly committed to engaging the industry and moving this process forward. By issuing this request, they are creating better clarity on how the industry can supply them with the right data to support the development of guidance that will enable them to effectively, appropriately, and compliantly communicate using these tools," said Gratton, who was also one of the presenters at the public hearings last November.

In her interview with Mr. Gratton, Dr. Kang provided clarification and direction to the industry, including the Agency's perspective on technology and social media, thoughts on the public hearing itself, what to expect from the ongoing guidance process, more details about the extended period for data submission, and her recommendations for what companies should be doing in the meantime.

Other highlights from the interview include Dr. Kang's comments on:

  • How the guidance process works
  • Why starting data gathering today is not useless
  • What the FDA can do to help
  • How best to stay apprised of new developments
  • When the FDA will make its next public appearance

"I think it's our responsibility as an industry to provide the FDA/DDMAC with as much supporting data as possible, so at the end of this journey we will have contributed to the development of guidelines that are specific enough to be actionable, broad enough to endure, and permissive enough to enable safe, effective, and responsible us
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SOURCE inVentiv Health
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