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Posts Showing search results for "ovasure"

Hello and welcome to the second half of the first Amplion company blog where I mapped out why our team is dedicated to seeing the promise of personalized medicine fully realized. So now I’m going to cover why we believe that 510(k)-style regulation of LDTs should not be pursued. 510(k) is…(Read More)

For those who were willing to listen through a lot of repetitive presentations during last week’s FDA workshop covering the Agency’s proposed regulation of LDTs, some interesting points were made by at least a few of the presenters and panelists. FDA Regulation Can’t Keep Pace With Innovation Dara Aisner, M.D., Ph…(Read More)

There have been some interesting developments over the last few weeks in the ongoing discussion about FDA’s desire to regulate LDTs. Pathologists Still Oppose Regulation At the annual meeting Nov. 12-14 of the Association for Molecular Pathology (AMP) a special late-breaking “Conversations with the FDA” session was held to discuss FDA’s…(Read More)

I finally had a chance to watch the complete Congressional hearing on LDT regulation that took place several weeks ago. Several interesting things came up which I haven’t seen mentioned anywhere else: – The issue of FDA’s authority to regulate LDTs may not in fact be settled. Congressman Michael Burgess (R, Texas) stated that…(Read More)

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