The American Association for Cancer Research has published a policy statement urging the FDA to regulate high risk LDTs. The fact that FDA intends to do so certainly isn’t news to anyone who is following the issue, but this is the first such statement that I...
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...
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...
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...
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...
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPT
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
