Welcome
Hello everyone. I am so excited to have the opportunity to be part of the XIFIN team and be able to share ideas with all of you around what it takes to be commercially successful in the new clinical diagnostics arena.
Posted by Rina Wolf on October 27, 2009
In this era of Health Care reform proposals which are morphing on an almost daily basis, concerns over what Comparative Effectiveness really means, discussions on issues surrounding gene patenting and the potential for increased FDA oversight, among other emerging issues, the challenges to successfully launching a product are growing and need to be considered at the very earliest stages of your product development. In the future, I would like to use this forum to discuss what we are hearing and how it can impact our business. For now, please let me know what your areas of interest and concern are so that we can tailor this forum to your needs. I look forward to hearing from you and beginning an animated and informative discussion.
Reader Comments
Posted by: Susan Liebowitz on November 13, 2009 at 11:47 pm
Potential FDA regulation, and other topicsPosted by: Rina on November 20, 2009 at 4:24 pm
Hi Susan,
Thanks for your interest. The following comments on potential FDA regulation are purely my opinion and do not represent any official statements.
Based on the meetings in which I have participated with FDA officials, it seems clear that their intent is to expand the scope of tests that will require clearance. My impression is that not only will we see a final IVDMIA guidance in 2010, but also some means of regulating all LDTs, likely on a tiered system based on perceived risk. The big questions re the IVDMIA guidance remain a clear definition and the allowed time for tests that are commercially available to come into compliance. The industry has requested 36 months and this seems reasonable, especially as whatever timeline is mandated will be greatly dependent on FDA resources.
My impression of Dr. Hamburg is that her goal is to create good policy. She seems open to two-way conversation re how molecular diagnostics and other new diagnostic technologies should be assessed and acknowledges that existing protocols may not be appropriate. Her challenge, as is ours, is to propose means other than traditional RTCs to definitively prove validation.
There are also other proposals on the table such as the one by CAP and by Congressman Patrick Kennedy.
It should be another interesting year!
Looking forward to your comments.
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