Following quickly on the heels of the AACR statement in support of FDA regulation of LDTs, the co-founder of The Coalition for 21st Century Medicine, Kathleen Wilsey, today presented to Congress testimony that includes significant concerns about the potential for...
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...
In response to congressional pressure, FDA has released a copy of its long-awaited draft guidance covering regulation of LDTs. FDA seems to have addressed many if not all of the concerns regarding negative impacts from LDT regulation, at least in writing the guidance....
In a recent letter to the Office of Management and Budget (OMB), the directors of 23 major clinical labs urged OMB to reject FDA’s draft guidance on LDT regulation. In this letter, one of the reasons given for rejecting FDA regulation of LDTs is that it would...
A letter was sent today to Brian Deese, Acting Director of OMB, by 23 lab directors urging him to withhold FDA’s draft guidance regarding LDT regulation. The bases for this resistance are fourfold: 1. LDTs are ubiquitous and vital to the practice of medicine; 2....
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.
